Pages: 1 2 3 [4] 5  All   Go Down
Print
Author Topic: Flashcard  (Read 27333 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #90 on: November 05, 2017, 02:14:21 AM »

Model Number MODEL 250
Event Date 08/27/2014
Event Type Malfunction
Event Description
The handheld and flashcard were received for analysis. Analysis is underway, but has not been completed to date.

Event Description
It was reported that the nurse was having trouble with the handheld. It was reported that an error message was found indicating "unknown card in slot 1. " troubleshooting was performed and the flashcard orientation was confirmed correct, no pins were bent, a hard reset was performed and the same message was given. A new programming tablet was provided to the hospital. The handheld is expected to be returned for analysis, but has not been received to date.

Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Analysis of the handheld was completed on 10/27/2014. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. Analysis of the flashcard was completed on 10/27/2014. During the analysis, it was verified that the flashcard contents could not be accessed using either a handheld or windows based computer. The cause for the anomaly is associated with a defective flashcard. Due to the nature of the flashcard defect, no further testing could be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4118629
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #91 on: November 07, 2017, 01:13:21 AM »

Model
« Last Edit: February 02, 2019, 08:56:49 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #92 on: November 10, 2017, 01:25:07 AM »

Model
« Last Edit: February 09, 2019, 01:26:02 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #93 on: November 10, 2017, 01:26:04 AM »

Model Number MODEL 250
Event Date 11/20/2014
Event Type Malfunction
Event Description
It was reported that the patient's handheld was not allowing the "database utilities" option to be selected when attempting to backup the data. Troubleshooting was performed; however, the data could not be successfully transferred to a blank flashcard. No patient's were affected by this issue. The handheld is expected to be returned for analysis, but has not been received to date. No additional relevant information has been received to date.

Manufacturer Narrative
Describe event or problem, corrected data: previously submitted mdr indicated that the suspected device is expected for return, but it is not expected for return. Type of device, name, corrected data: previously submitted mdr indicated that the suspect device is the handheld device, but it was the software.

Manufacturer Narrative

Event Description
Follow up showed that no other issues were encountered with the handheld device or software, and no other issues had been reported since. The handheld device is not expected for return. Based on the sequence of events, the issue appears to be due to incomplete insertion of the flashcard into the handheld device as this is expected behavior if no flashcard is inserted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4330577
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #94 on: November 20, 2017, 03:01:56 AM »

Model Number MODEL 250
Device Problem Device operates differently than expected
Event Date 01/01/2015
Event Type Malfunction
Event Description
An internal discussion between quality engineering and software engineering discovered that the software file corruption is believed to be the result of the user removing the software flashcard from the programming handheld, and then inserting it into another computer, at which point the files were intentionally (by user) or unintentionally (by computer) manipulated. In support of this, product analysis verified proper functionality of the handheld and the flashcard itself, and showed that once the files were reinstalled, there were no issues.

Event Description
Analysis was completed on the returned programming handheld. No anomalies associated with the handheld operating system were identified during the analysis. The handheld performed according to functional specifications. Analysis was completed on the returned programming software. An analysis of the returned flashcard identified that its memory had been corrupted. As a result of the corruption, the installation and vns files were no longer accessible. A cause for the memory corruption is unknown and could not be determined. Once the flashcard was formatted and new installation software was installed, the flashcard performed with no observed anomalies.

Event Description
It was reported that the vns programming handheld is malfunctioning. Attempts to obtain additional relevant information have been unsuccessful to date. The handheld is expected to be returned for analysis, but has not been received to date.

Event Description
Additional information was received that the issue experienced was that the vns software was not showing upon start-up, only the handheld desktop. It was reported that this issue only occurred once. The issue was isolated to the programming handheld. It was reported that the issue occurred regardless of whether the handheld was plugged into a wall outlet or not. There is no known trauma or bad storage conditions for the handheld. The programming handheld and software have been received by the manufacturer for analysis; however, analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4771765
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #95 on: November 24, 2017, 03:46:59 AM »

Model Number MODEL 250
Device Problems Defective item; Computer operating system issue
Event Date 02/01/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
During the investigation in manufacturer report #(b)(4), analysis of the returned software flashcard identified that the software could not load into the returned handheld. The cause for the anomaly is associated with a defective flashcard that could not be accessed using a handheld. The root cause for the failure could not be identified during the analysis. Further analysis identified that the flashcard could be read using a pc computer. The contents of the returned flashcard were copied onto a known good flashcard and no anomalies associated with the returned software were identified.

Event Description
The flashcard was sent to the manufacturer and the cause for the anomaly is associated with a damaged connector pin. No other anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4909298
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #96 on: November 25, 2017, 07:45:14 AM »

Model Number MODEL 250
Device Problems Computer operating system issue; Programming issue
Event Date 07/29/2015
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative
The previously submitted mdr inadvertently provided the wrong suspect device for the event.

Event Description
It was reported that a programming computer was performing very slowly. It was reported that it was impossible to download the data from the computer as the database utilities button was not active. Review of manufacturing records confirmed that the programming computer passed all functional tests prior to distribution. The suspected programming computer was returned to the manufacturer. Analysis is underway but it has not been completed to date.

Event Description
An analysis was performed on the returned handheld. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. An analysis was performed on the returned flashcard. The cause for the reported anomaly is associated with a bent pin in the flashcard that made the card inaccessible. No further anomalies associated with flashcard performance were identified during the flashcard analysis. The reported slow performance issue was not verified during analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5020571
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #97 on: December 01, 2017, 02:01:19 AM »

Model Number MODEL 250
Device Problem Device operates differently than expected
Event Date 08/01/2015
Event Type Malfunction
Event Description
It was reported that the physician's handheld freezes persistently on the interrogation screen. Hard resets have been performed which helped on some, but not all occurrences. The physician was provided a new programming computer and the handheld and flashcard were received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Product analysis was completed for the handheld device. No anomalies associated with the handheld performance were noted during testing. The handheld performed according to functional specifications. Product analysis was completed for the software flashcard. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. During the analysis it was identified that the flashcard contained a mac osx operating system file and folders. The presence of the file and folders is an indication that the flashcard was inserted into a device using the mas osx operating system. The file and folders had no impact on the vns software performance. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5054929
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #98 on: December 11, 2017, 02:10:47 AM »

Model Number MODEL 250
Event Date 12/15/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
This manufacturer report captures the software flashcard as the suspect device for the events reported in mfr. Report # 1644487-2016-00062 which captures the handheld device as the suspect device. The handheld device and software flashcard were returned to the manufacturer for analysis which was completed on 02/09/2016 and identified that the vns software would not load when the returned flashcard was inserted. The cause for the anomaly was associated with a bent pin found in both the handheld flashcard slot and the software flashcard socket. Once the pins were straightened, no further anomalies the handheld and software flashcard were noted. Based on the information available, the root cause of the bent pin is most likely due to the user inserting the flashcard incorrectly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5430758
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #99 on: December 11, 2017, 02:11:24 AM »

Model Number MODEL 250
Event Date 01/28/2016
Event Type Malfunction
Event Description
During the analysis of a returned handheld computer due to a reported frozen screen (event reported via medwatch 1644487-2014-01635), it was identified that a known good flashcard could not be fully inserted into the returned handheld. The cause for the anomaly is associated with a bent flashcard slot pin. Once the pin was straightened, no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5436381
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #100 on: December 18, 2017, 01:16:56 AM »

Model Number MODEL 250
Event Date 04/19/2016
Event Type Malfunction
Event Description
The handheld and flashcard were received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Analysis of the handheld was completed on 07/01/2016. No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. Analysis of the flashcard was completed on 07/01/2016. The flashcard file system "as received" was found to be corrupt. As a result of the file system corruption, the flashcard was unreadable and could not load the vns software onto the handheld. Once the flashcard was formatted and new installation software was copied onto the flashcard, no anomalies associated with the flashcard performance were identified during the flashcard analysis. It was also identified that the 2577 folder was inaccessible using a pc computer and the cyberonic sbu. Cdb and archive database (b)(4) files were 0kb in size. These anomalies are an indication that the files and folder on the returned flashcard are also corrupt. It is generally unknown when or how the flashcard files were corrupted based on the available information, although the corrupt files do show a modification date of (b)(6) 2015 (assuming that the date on the handheld was correct at the time of the event).

Event Description
It was reported on 04/19/2016 that a physician's programming software would not work. The company representative was attempting to extract data, but the device froze on the start-up screen. The battery was replaced, but the issue continued. The programming software version could not be provided as the device was frozen on the start-up screen. The handheld and flashcard are expected to be returned for analysis, but have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5658066
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #101 on: January 09, 2018, 02:09:07 AM »

Model Number 250
Event Date 12/09/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a vns (b) (4) handheld computer screen was freezing during interrogation. Reseating the flashcard resolves the freezing. The serial adapter cord is also loose and needs to be pushed in, in order for the handheld computer to function. The handheld computer and flashcard have been received and are currently in product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1360937
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #102 on: January 10, 2018, 01:24:58 AM »

Model Number 250
Event Date 04/29/2009
Event Type Malfunction
Event Description
It was reported that a neurosurgeon encountered a frozen screen with a dell x5 handheld computer. Further info received indicated that the frozen screen was at the successful interrogation screen and re-seating the flashcard resolved the issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1428041
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #103 on: January 25, 2018, 02:25:00 AM »

Model Number 250
Event Date 05/01/2010
Event Type Malfunction
Manufacturer Narrative
Conclusions: device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported by the physician that their hand held was not holding a charge as long, and the physician requested a new programming system. The programming system was returned to manufacturer for analysis. Analysis of the programming wand revealed no anomalies and the device performed according to specifications. Analysis of the hand held revealed that the hand held main battery was able to hold a charge with no observed anomalies. During the analysis, it was identified that the main battery was swollen. A possible contributor to the observed battery swelling is age and exposure to repeated charge and discharge cycles over the life of the hand held. The swollen battery had no functional impact on the device performance. During the analysis, no functional anomalies associated with the hand held performance were identified. The hand held performed according to functional specifications. Analysis of the software flashcard was performed, and it was identified that the flashcard contained 2 different sets of databases. The cause for the multiple sets of databases is associated with the flashcard being inserted into multiple devices (most likely to transfer the (b)(6) data to the new (b)(6) handheld). The presence of the different sets of databases did not contribute to any performance issues. No further anomalies were identified during the analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1807065
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #104 on: January 27, 2018, 01:31:41 AM »

Model Number MODEL 250
Event Date 12/14/2011
Event Type Malfunction
Event Description
Further information was received from the area representative indicating that she troubleshot the nurse's handheld and found that the flashcard was just out. The area representative indicated that she pushed the flashcard back into place and the handheld was functional.

Event Description
It was reported by a nurse that her handheld computer was not working correctly and noted that her flashcard memory was not properly inserted. The nurse indicated that she could not get the flashcard back into place and needed assistance. At the moment good faith attempts to obtain further information regarding the event and troubleshooting remain unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405080
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #105 on: February 05, 2018, 01:49:10 AM »

Model Number MODEL 250
Event Date 03/07/2011
Event Type Malfunction
Event Description
It was initially reported that there were issues with the physician handheld. The screen would frequently go blank and it required the handheld to be turned off and on to fix the problem. When personnel initially went to use the handheld on the day of the report, the screen was blank with the handheld fully charged. Then the handheld would not progress to allow for the retrieval of pt data. A hard reset was performed but would not progress past the "clear all data" screen. It was confirmed that the button left of center (contacts) was being pressed but the reporter stated that it did not work. It was confirmed that the battery latch cover was secure, all connections were secure, and when the device was plugged in, the power light turned orange. A second hard reset was attempted and again it did not move past the "clear all data" screen. The handheld and flashcard were returned to the manufacturer for eval. The flashcard and software performed according to functional specifications. During the analysis, it was identified that the flashcard contained two different sets of pt databases. The cause for the anomaly is associated with the flashcard being inserted into another handheld while out in the field. Based on the modification date of the cyberonicsbu database, the reported database anomaly could not have contributed to the reported software error. During the analysis no anomalies associated with flashcard software performance was identified. The cause for the reported complaint is associated with a loose/disconnected cable in the handheld that made the contacts button unresponsive. Once the cable was reseated to the main board, no further anomalies were identified. No anomalies associated with the handheld software were identified during the analysis.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2062001
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #106 on: March 08, 2018, 01:19:03 AM »

Model Number MODEL 250
Event Date 05/23/2012
Event Type Malfunction
Event Description
Product analysis was completed on the handheld computer and related software/flashcard. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. In addition, no anomalies associated with the handheld operating system were identified during the analysis. It was identified that the lock button was in the locked position, and the flashcard was inserted backwards. These anomalies could not have contributed to the event (reported successful hard reset and crosshairs on alignment utility responded to screen taps). Once the lock button was moved to the unlocked position and the flashcard was inserted correctly, the handheld performed according to functional specifications.

Event Description
It was reported that a physician's handheld computer would not progress past the screen alignment page. A hard reset was performed, and the computer would still not complete the alignment and was continually showing the crosshairs (being stuck in a loop). A replacement computer was provided to the physician, and the computer and related flashcard was received by the manufacturer on (b)(4) 2012. The flashcard was returned inserted backwards in the computer. Product analysis has not completed to date.

Manufacturer Narrative

Manufacturer Narrative
Type of device name, corrected data: the initial report inadvertently reported the name incorrectly. The malfunction was on the handheld computer. Type of report, corrected data: the initial report inadvertently excluded the checkbox indicating that this is a '30-day' report. Manufacturer date, corrected data: the initial report inadvertently reported the incorrect date. It was initially reported for the software.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2616193
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #107 on: March 15, 2018, 12:52:43 AM »

Model Number MODEL 250
Event Date 08/28/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012 when it was reported that the physician's handheld was able to be successfully upgraded with a different flashcard. The manufacturer's consultant reported that he has the flashcard that didn't work and will be sending it back for product analysis. The flashcard has not been received for product analysis to date.

Event Description
On (b)(6) 2012 it was reported that a software upgrade would not work with a new flashcard on the physician's handheld. The manufacturer's consultant indicated that water got on some of these new flashcards when they were left outside during a rainstorm. Attempts for additional information are underway but have been unsuccessful to date.

Manufacturer Narrative

Event Description
The manufacturer's consultant reported that he sent in the flashcard for product analysis; however it has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2759590
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #108 on: March 18, 2018, 12:19:37 AM »

Model Number MODEL 250
Event Date 09/25/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
Reporter indicated a vns dell x5 computer was displaying an "vns executing sql error" message when attempting to use the vns software. It was confirmed that the flashcard was inserted properly, and a hard reset of the computer did not resolve the issue. It is suspected the software may be corrupted. Attempts for return of the computer are in progress.

Event Description
The handheld and flashcard were received on (b)(6) 2012 and analysis has since been completed. An analysis was performed on the handheld and no anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. An analysis was performed on the returned flashcard and the reported allegation was verified. During the analysis it was verified that the software would display sql error messages following an interrogation. The cause for the sql errors is associated with a corrupt database. A cause for the file corruption could not be determined based on the available information. No other anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2798104
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #109 on: March 19, 2018, 01:00:16 AM »

Model Number MODEL 250
Event Date 09/18/2012
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Product analysis was completed on the vns computer, flashcard, and programming wand. No anomalies were noted with the computer, and the computer performed per specifications. The flashcard and software performed according to specifications. During the analysis it was identified that the flashcard contained 2 pc2003 archive databases. The most likely cause for the databases being on the flashcard is associated with the flashcard being inserted into a pc2003 device (possibly to transfer patient data from one handheld to another). Since the pc2003 databases were archive copies and not the current database, they had no functional impact on the device performance. Screen freezing was not observed during the analysis. No anomalies were identified during the wand analysis, and the wand performed per specifications.

Event Description
Reporter indicated that a vns dell x50 computer screen was dark, frozen, and had shown a "fault report" immediately before going dark. The "shutdown" buttons are not working properly. Performing a reset on the computer did not resolve the issues. The computer, programming wand, and flashcard have been returned and are pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2795004
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #110 on: March 19, 2018, 01:01:10 AM »

Model Number MODEL 250
Event Date 09/17/2012
Event Type Malfunction
Event Description
It was reported by a representative, that during the upgrade of the physician's handheld he was receiving a message stating "unrecognized card, enter device driver for card. " or "enter name of device. " two different flashcards were tried with the same result. The software could not be installed, so the handheld was returned. Analysis on the handheld has since been completed. During the analysis it was identified that the vns software would not install into the handheld when the retuned flashcard was inserted. The cause for the anomaly is associated with 2 bent pins in the handheld flashcard slot. Once the pins were straightened, no further anomalies were identified. During analysis of the returned flashcards, no anomalies associated with flashcard software or databases were identified. The returned flashcards and software performed according to functional.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury. Additionally while device failure occurred, the likely cause is user error/ mishandling of the device.

Event Description
Follow up was performed with the manufacturer's representative; however he was unable to say if the flashcard inadvertently inserted backwards before or during the upgrade attempt.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2785335
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #111 on: March 20, 2018, 12:34:16 AM »

Model Number MODEL 250
Event Date 09/24/2012
Event Type Malfunction
Event Description
A company representative reported on (b)(6) 2012 that he was attempting to upload v8. 1 software to a physician's dell x50 handheld computer, and he was receiving an error message "unrecognized card: unknown card in socket 1. " he tried a hard reset and then attempted to upload the v8. 1 flashcard but again received warning message. He then tried to perform the upload process from v7. 1 to v8. 1 software, but he was unable to select the cf card as it did not appear on screen. The dell x50 handheld computer was received by the manufacturer for analysis on (b)(6) 2012. An analysis was performed on the returned flashcard, and a cause for the reported allegation was identified. The cause for the reported complaint is associated with a defective flashcard. A visual analysis of the pcb identified that a pin of the flashcard header was not soldered onto the pcb causing the handheld to not recognize the flashcard when it was inserted. Once the pin was soldered onto the pcb, no further anomalies were identified. This was a manufacturer-related issue. An analysis was performed on the returned handheld and the reported allegation was verified. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2785668
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #112 on: March 22, 2018, 12:11:10 AM »

Model Number MODEL 250
Event Date 11/07/2012
Event Type Malfunction
Event Description
It was reported on (b)(6) 2012 that the handheld was showing an error message of "executing sql statement";. No further information was provided. The handheld, flashcard, and serial cable were returned to the manufacturer for product analysis on (b)(6) 2012. Product analysis is still underway and has not yet been completed.

Event Description
Additional information was received on (b)(6) 2012 when product analysis was completed on the handheld and flashcard. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. An analysis was performed on the returned flashcard and during the analysis it was verified that the handheld would display sql error messages following interrogations. The cause for the sql errors is associated with an incompatible database version. The cyberonicsbu database was a pc2002 database, and it is not compatible with the pc2003 handheld. The cause for the database incompatibility is associated with the flashcard being inserted into multiple handheld devices. No other anomalies associated with flashcard software or databases were identified during the flashcard analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2851511
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #113 on: March 23, 2018, 01:27:05 AM »

Model Number MODEL 250
Event Date 11/07/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012 when product analysis was completed on the handheld and flashcard. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. An analysis was performed on the flashcard and no anomalies that could have contributed to the frozen screen event were identified during the flashcard analysis. During the analysis it was identified that the flashcard contained 4 different patient database files. The most likely cause for the multiple databases is associated with the flashcard being inserted into multiple handhelds. No other anomalies were identified.

Manufacturer Narrative

Event Description
On (b)(6) 2012 it was reported that the handheld's screen was freezing from time to time. It was noted that doing a hard reset would not help the issue. No further information was provided at the time. The handheld, flashcard, and serial cable were returned for product analysis on (b)(6) 2012. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2851417
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #114 on: March 24, 2018, 01:40:33 AM »

Model Number MODEL 250
Event Date 10/18/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6), 2012 when it was reported that the wand was functioning properly, it was only the handheld that was not functioning. The flashcard lot number was also noted to be 874824. It was reported that a hard reset has been performed on the handheld and still the problem persisted. It was also reported that the handheld would be sent back to the manufacturer for product analysis but it has not yet been received.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when it was reported that it appeared that the handheld was stuck on the screen alignment loop and therefore a hard reset will not fix this permanently. Attempts for the return of the handheld have been made but it has not been returned to the manufacturer for product analysis to date.

Event Description
On (b)(6) 2012, it was reported that a part of the touch screen on the handheld did not work and therefore the handheld could not be used. It was clarified that the screen is frozen and the user cannot access the next steps. It was reported that the handheld was not dropped and hat this is not happening because of the lock on the handheld. The handheld is new and had just been taken out of the box to install a new program when they realized that it was not working. The handheld does turn on; the touch screen is just not functional. The screen that the handheld froze on was the screen alignment where the user is requested to tap the screen in order to align it. It is likely that the handheld will be returned to the manufacturer for product analysis; however it has not been received to date.

Event Description
Additional information was received on (b)(6) 2012 when the handheld and flashcard were returned for product analysis. Product analysis was completed on (b)(6) 2013. During the analysis of the flashcard it was identified that the flashcard contained two different sets of patient databases. The most likely cause for the anomaly is associated with the flashcard being inserted into multiple handheld devices; this had no adverse effect on software functionality. No other anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications. Product analysis on the handheld revealed no anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2835799
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #115 on: March 28, 2018, 12:47:25 AM »

Model Number 250
Event Date 11/22/2012
Event Type Malfunction
Event Description
An analysis was performed on the returned flashcard. A review of the software in the returned handheld gives the indication that an upgrade was successfully completed on the returned handheld. An analysis was performed on the returned flashcard and the reported allegation was verified. The cause for the reported allegation is associated with a missing 2577 folder that contains the vns installation files. Since the files were missing, the software was unable to be installed into the handheld. A root cause for the missing files could not be determined based on the available information. No other anomalies were identified.

Event Description
Our regional manager in (b)(6) reported that a handheld computer is not working. The programming software does not start even after resetting. They performed several resets and only the windows screen appears. The handheld and software were returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2881812
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #116 on: April 02, 2018, 12:20:17 AM »

Model Number MODEL 250
Event Date 12/20/2012
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative

Event Description
The vns computer and flashcard were received for analysis on (b)(4) 2013. Analysis of the computer serial cable was previously reported on the initial mdr, and a failure was confirmed. During the analysis, no anomalies associated with the handheld computer performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. During the analysis it was identified that the flashcard contained 2 different sets of patient databases. The likely cause for the multiple databases is associated with the flashcard being inserted into multiple devices. However, this did not affect device function. No other anomalies were identified. The flashcard and software performed according to functional specifications.
 
Event Description
Reporter indicated a vns dell x50 computer was not working properly; "the data transfer is working ok but it does not recharge the pda. " the serial cable was returned for analysis. During the analysis it was identified that the serial cable power connector had an open in the power plug that prevented the ac adapter from powering the handheld. X-ray analysis identified that the negative wire of the cable was no longer soldered onto the barrel connector. As a result, the serial cable was unable to provide power to the handheld using the ac adapter. No other anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2931871
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #117 on: April 11, 2018, 02:30:21 AM »

Model Number MODEL 250
Event Date 02/14/2013
Event Type  Malfunction   
Event Description
It was reported that the handheld will not "use" the version 8. 1 flashcard. It was later reported that a manufacturer employee visited the site to troubleshoot the event. During troubleshooting the manufacturer employee noted that when trying to upgrade the handheld from the version 7. 1 flashcard to the version 8. 1 flashcard the software did not load on the handheld. The employee reinserted the version 7. 1 flashcard into the handheld and performed a hard reset on the handheld successfully. The handheld displayed the version 7. 1 software. The manufacturer employee updated the date and time on the handheld and then replaced the version 7. 1 flashcard with the version 8. 1 flashcard; however, the installation process never began. The employee once again inserted the version 7. 1 flashcard, which again loaded the version 7. 1 software on the handheld. Another version 8. 1 flashcard with the same lot number was inserted into the handheld, which resulted in a message "unrecognized card in socket 1". A new handheld was shipped to the physician's office. The handheld and both version 8. 1 flashcards are expected to return to manufacturer for product analysis; however, have not been received to date.
 
Event Description
Attempts to have the device returned to manufacturer for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3006811
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #118 on: April 30, 2018, 12:15:16 AM »

Model Number 250
Event Date 05/09/2013
Event Type  Malfunction   
Event Description
Analysis was performed on the returned handheld, and the reported allegation was verified. During the analysis, it was identified that the sync cable connector on the bottom of the handheld was damaged. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. During the analysis of the returned software/flashcard, it was identified that the flashcard contained two different sets of patient databases. The likely cause for the multiple databases is associated with the flashcard being inserted into multiple devices. No other anomalies were identified. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
The initial report inadvertently listed the incorrect device name. The initial report inadvertently listed the incorrect date. Review of the handheld computer device history records confirmed all quality tests were passed prior to distribution.
 
Manufacturer Narrative

Event Description
A vns consultant reported that her handheld computer was not turning on. She stated that it has been charging since yesterday, and she tried charging it on different outlets. She also noted that the light was on when it was plugged in. It was confirmed that the lock button was not engaged. A hard reset was performed which still did not resolve the issue. The handheld was returned for analysis and is pending completion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3144570
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #119 on: May 01, 2018, 12:13:38 AM »

Model Number MODEL 250
Event Date 07/08/2013
Event Type  Malfunction   
Event Description
Additional information was received that product analysis was completed on the handheld and flashcard. No anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The handheld performed according to functional specifications. The cause for the reported (b)(4) error messages is associated with an incompatible database. During the analysis it was identified that the patient databases were associated with the pc2002 operating system. Because they are associated with the pc2002 operating system, they are not compatible with the returned (b)(4) device that uses the pc2003 operating system. The cause for the database incompatibility issue is associated with the flashcard being transferred from a (b)(4) handheld to the (b)(4) handheld. No other anomalies were identified during the analysis.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated a vns dell x5 computer with 8. 1 software displayed ¿error executing sql statement" messages when attempting to interrogate a patient. Performing a hard reset resolved the error, but the error occurred again and was not resolved by performing a hard reset. The computer and flashcard were received to the manufacturer on (b)(4) 2013 and are pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3247834
Logged
Pages: 1 2 3 [4] 5  All   Go Up
Print
Jump to: