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Author Topic: Touchscreen  (Read 40442 times)
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dennis100
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« Reply #30 on: March 08, 2017, 04:11:43 AM »

Model Number 250
Event Date 03/16/2010
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported that a neurologist's handheld computer was not responsive at the main screen while pressing any of the buttons. The event resolved after a soft reset was performed and the physician was able to navigate and interrogate his demo generator. Further info was received from the physician stating that his handheld computer was unable to exit the screen after diagnostic results were displayed. A hard reset was performed and the event resolved. A new handheld was sent to the physician and the reported handheld was returned to the manufacturer to undergo product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1661668
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dennis100
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« Reply #31 on: March 09, 2017, 01:43:18 AM »

Model Number 250
Event Date 09/30/2009
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a vns therapy programming system handheld computer could not advance past the alignment screen. The cross does move around the screen when the center of the screen is pressed with the stylus. Troubleshooting did not resolve the issue. Good faith attempts to obtain the product for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1542551
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dennis100
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« Reply #32 on: April 23, 2017, 01:29:32 AM »

Model Number 250
Event Date 12/01/2009
Event Type Malfunction
Event Description
It was reported that the site was having issues with the handheld and it would keep freezing on the interrogation successful screen. The site could fix the issue by performing soft reset every time. The manufacturer has already identified that under certain types of conditions, this screen freeze event can occur with the (b) (6) handheld computer. New handheld was shipped to the site and the old handheld was returned to the manufacturer and is currently undergoing product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575845
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dennis100
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« Reply #33 on: April 23, 2017, 01:30:04 AM »

Model Number 250
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was initially reported that the site's handheld computer was freezing on interrogation, which would be resolved with a soft or hard reset, as this is a known issue to occur with the (b) (4) software. Since the issue continued to occur, the site requested a replacement handheld computer. The handheld computer with flashcard/software was returned to the manufacturer for analysis. No anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. As a result, no other failure was identified with the (b) (4)/software and the device performs according to specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575852
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dennis100
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« Reply #34 on: April 23, 2017, 01:30:37 AM »

Model Number 250
Event Date 10/24/2009
Event Type Malfunction
Event Description
It was initially reported that the physician was requesting a new programming system due to his handheld freezing intermittently upon interrogation. The issue was said to have been occurring over the last month. Troubleshooting was performed, which did not appear to resolve the issue. Good faith attempts to obtain the programming system for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575854
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dennis100
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« Reply #35 on: April 23, 2017, 01:31:08 AM »

Model Number 250
Event Date 11/24/2009
Event Type Malfunction
Event Description
It was reported that a neurologist's (b) (6) handheld computer was freezing on the interrogation successful screen. A company representative performed troubleshooting on the reported handheld and after performing a soft reset the issue resolved. A new handheld was sent to the neurologist and the reported handheld was returned to the manufacturer to undergo product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575863
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dennis100
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« Reply #36 on: April 23, 2017, 01:31:36 AM »

Model Number MODEL 250
Event Date 11/01/2009
Event Type Malfunction
Event Description
It was reported that the site's handheld would continually freeze following successful interrogations and other screens. It is unk if troubleshooting was performed to resolve the event but the site requested that a new device be sent to replace the non-working device. The non-working device has been returned to the mfr and analysis is underway. However, it is unk that under certain conditions this type of screen freeze event can occur with the (b)(4) handheld computer and cyberonics (b)(4) software.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577165
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dennis100
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« Reply #37 on: April 23, 2017, 01:32:12 AM »

Model Number MODEL 250
Event Date 11/30/2009
Event Type Malfunction
Event Description
It was reported that the physician's handheld computer started freezing at the interrogation screen on (b) (6)2009. The physician has tried a soft and hard reset when this occurs and it works sometimes. Product was returned to the mfr, but analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581628
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dennis100
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« Reply #38 on: April 23, 2017, 01:32:41 AM »

Model Number 250
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that the site's (b) (4) handheld would not move past the (b) (4) screen. The manufacturer representative went to the site to troubleshoot the problem. A hard reset was performed, by removing and re-inserting the battery, and the (b) (4) screen appeared. The align screen appeared and the device did not respond to the stylus touch, and would thus not move past this screen. The non-working hand held has been returned to manufacturer where analysis is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581632
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dennis100
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« Reply #39 on: April 25, 2017, 01:39:34 AM »

Model Number 250
Device Problems Crack; Device inoperable
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that a physician's office was having issues with their programming system. They indicated that the screen was cracked and the device was inoperable. The site was sent a new handheld device and flashcard and the old one was returned to the mfr for analysis however device eval has not been completed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577001
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dennis100
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« Reply #40 on: April 25, 2017, 01:40:24 AM »

Model Number 250
Event Date 11/01/2009
Event Type Malfunction
Event Description
It was reported that the user's handheld froze following a successful interrogation. Reseating the flashcard temporarily resolved the freezing screen; however, the site requested that a new device be sent to replace the non-working device. The non-working device has been returned to the mfr and analysis is underway. However, it is known that under certain conditions this type of screen freeze event can occur with the (b)(4) handheld computer and cyberonics (b)(4) software.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577006
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dennis100
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« Reply #41 on: April 26, 2017, 12:13:03 AM »

Model Number 250
Event Date 12/01/2009
Event Type Malfunction
Event Description
Initial reporter indicated that their (b) (6) handheld computer containing 7. 1 programming software would not past the blank screen with hr001. A hard reset was attempted, and it still did not work. The handheld computer is at manufacturer pending completion of product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575414
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dennis100
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« Reply #42 on: April 27, 2017, 01:05:03 AM »

Model Number 250
Event Date 11/23/2009
Event Type Malfunction
Event Description
It was reported that the physician was having difficulties with their hand held. The manufacturer rep went to the site to troubleshoot the programming system and during an attempt to interrogate a demo generator; the hand held screen froze during the initial interrogation. A hard reset was performed on the hand held, and an interrogation was successfully performed. The rep provided the physician and staff with the troubleshooting steps to resolve the frozen screen. The site did not request a new device be sent, therefore, the device will not be returned to manufacturer for analysis. The manufacturer has already identified that under certain type of conditions, this screen freeze event can occur with the (b) (6) handheld computer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1571650
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dennis100
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« Reply #43 on: April 27, 2017, 01:05:35 AM »

Model Number MODEL 250
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that the physician's (b) (6) handheld computer, was getting stuck at the interrogation screen. He stated it happened to him before an it resolved, but then it happened again and did not resolve. Product has been requested, but has not been returned to mfr to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575246
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dennis100
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« Reply #44 on: April 27, 2017, 01:06:12 AM »

Model Number MODEL 250
Event Date 10/01/2009
Event Type Malfunction
Event Description
It was reported that a physician was having some issues with the programming handheld device. The screen would freeze on the interrogation screen. A soft and hard reset were performed; however, once the hard reset was performed, it took about five minutes for the main screen to load. According to the physician, this issue began about a month prior to her reporting it to the mfr. The physician was sent a replacement handheld and attempts to obtain the physician's old handheld are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1575248
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dennis100
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« Reply #45 on: April 28, 2017, 12:46:57 AM »

Model Number MODEL 250
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that a physician's handheld device was freezing during interrogation and the physician wanted it replaced. A replacement handheld device has been sent to the physician and good faith attempts to obtain the old handheld device for product analysis are in process.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1580749
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dennis100
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« Reply #46 on: April 28, 2017, 12:47:47 AM »

Model Number 250
Event Date 11/03/2009
Event Type Malfunction
Event Description
It was reported that the (b)(4) handheld computer was freezing on the interrogation successful screen. The problem resolved with resetting flashcard, but the site requested a replacement system. Product has been requested, but has not been returned to the mfr to date.

Manufacturer Narrative
Device failure is suspected, 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=1569673
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dennis100
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« Reply #47 on: April 28, 2017, 12:48:37 AM »

Model Number 250
Event Date 11/05/2009
Event Type Malfunction
Event Description
Reporter indicated that a vns (b) (4) handheld computer was frozen on the "delete memory" screen. The suspect computer and flashcard have been returned and are now in product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1569672
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dennis100
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« Reply #48 on: April 28, 2017, 12:49:21 AM »

Model Number 250
Event Date 11/02/2009
Event Type Malfunction
Event Description
It was reported to manufacturer that the physician's hand held screen was frozen at the interrogation screen. Troubleshooting was performed which included both soft and hard resets and ensuring that the screen lock button was in the unlock position, however, the issue did not resolve. The physician has been sent a new hand held. Good faith attempts to obtain the non-working hand held and software for analysis are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570472
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dennis100
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« Reply #49 on: April 28, 2017, 12:50:31 AM »

Model Number 250
Device Problem No display or display failure
Event Date 11/01/2009
Event Type Malfunction
Event Description
It was reported by the physician that their handheld screen has been freezing during interrogation. Handheld was rebooted but the problem continues to persist. The manufacturer has already identified that under certain type of conditions this screen freeze event can occur with the (b) (4) handheld computer. New handheld was shipped to the site and the old handheld was returned to manufacturer for product analysis. Analysis was completed on the handheld and no obvious anomaly was noticed. Analysis on the flashcard was completed and the screen freeze event was not duplicated. The flashcard and software performed according to specifications. However, manufacturer has already identified that under certain type of conditions this screen freeze event can occur with the (b) (4) handheld computer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570351
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dennis100
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« Reply #50 on: April 28, 2017, 12:51:21 AM »

Model Number 250
Event Date 11/20/2009
Event Type Malfunction
Event Description
It was reported that a surgeon's (b)(4) handheld computer was frozen on the "interrogation successful" screen while in the operating room for an initial implant. Further information from the surgeon revealed that re-seating the flashcard resolved the issue. Currently a new handheld was sent to the surgeon and the old handheld is to be returned to the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570346
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dennis100
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« Reply #51 on: April 28, 2017, 12:52:24 AM »

Model Number 250
Event Date 12/02/2009
Event Type Malfunction
Event Description
Initial reporter indicated that her handheld computer containing 7. 1 programming software was frozen on the successful interrogation screen. A soft reset was performed which resolved the problem and handheld computer worked properly. The product was not returned to the manufacturer. This is a known event with the 7. 1 programming software.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570469
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dennis100
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« Reply #52 on: April 28, 2017, 12:53:07 AM »

Model Number MODEL 250
Event Date 10/28/2009
Event Type Malfunction
Event Description
Initial reporter indicated that their (b) (6) handheld computer had a frozen screen which resolved after removing and reinserting the flashcard. The handheld contained 7. 1 programming software.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1550890
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dennis100
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« Reply #53 on: April 28, 2017, 12:53:54 AM »

Model Number MODEL 250
Event Date 10/30/2009
Event Type Malfunction
Event Description
Reporter indicated a vns therapy programming handheld computer screen would not align. The touch button at the bottom of the handheld is not working which does not allow her to have the screen aligned. The handheld has been returned to the manufacturer and is pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1551274
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dennis100
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« Reply #54 on: April 29, 2017, 12:33:02 AM »

Model Number 250
Event Date 01/01/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated the physician's hand-held computer was freezing after interrogation. Troubleshooting did not resolve the issue. The hand-held was returned to the manufacturer and a product analysis was performed. During the analysis it was identified that the hand-held had intermittent communication issues. Visual analysis of the serial cable identified that the connector plug assembly was worn and that the metal cover of the dell axim connector plus assembly was loose allowing an intermittent connection between the hand-held and serial cable. No further anomalies on the device performance were noted during testing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1015918
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dennis100
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« Reply #55 on: April 29, 2017, 12:33:52 AM »

Model Number MODEL 250
Event Date 03/06/2008
Event Type Malfunction
Event Description
Initial reporter indicated that their dell handheld "screen freezes upon interrogation and reinserting the flashcard resolves the issue and it reoccurs. " mfr is pending receipt of the product for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1023676
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dennis100
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« Reply #56 on: May 11, 2017, 12:10:59 AM »

Model Number 250-7.1
Event Date 01/08/2008
Event Type Malfunction
Event Description
The reporter indicated that the (b) (4) hhd was freezing during interrogations. The handheld computer was unresponsive to stylus tapping. In addition, the interrogation process would time out on several occasions. The reporter indicated that the problem reoccurred, once within ten attempts. After a hard reset and re-alignment of the handheld screen, the reported event was resolved through troubleshooting.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=992185
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dennis100
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« Reply #57 on: May 15, 2017, 12:18:24 AM »

Model Number 201
Event Date 01/01/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that a site's handheld would freeze at the interrogation screen and was never able to get past it. A replacement handheld was sent to the site and they were still not able to interrogate. They've only been able to interrogate successfully once. Troubleshooting was performed. The handheld was used unplugged, the programming wand battery was checked and they ensured there was no electromagnetic interference in the room. The nurse tried using another programming wand and this worked successfully. Product return and analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1105288
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dennis100
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« Reply #58 on: May 18, 2017, 12:22:05 AM »

Model Number 201
Event Date 10/29/2008
Event Type  Malfunction   
Event Description 
It was reported that a surgeon was experiencing a frozen screen after the interrogation successful screen was received on his handheld device. The physician felt that there may be a bad connection between the handheld device and the programming wand. Both devices were replaced. The wand has been received for product analysis however, device evaluation has been completed.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1248357
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dennis100
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« Reply #59 on: May 19, 2017, 01:09:45 AM »

Model Number MODEL 250
Event Date 10/23/2008
Event Type  Malfunction   
Event Description 
Initial reporter indicated that she was in the o. R. And was having problems with screen freeze on the interrogation screen with her (b) (4) handheld computer. It contained 7. 1 programming software. Troubleshooting was performed and the screen freeze resolved. She performed an interrogation and it worked "ok. " device malfunction of the software suspected that resolved with a flashcard reinsertion.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1236858
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