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Author Topic: Touchscreen  (Read 29102 times)
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dennis100
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« Reply #240 on: December 23, 2018, 10:31:26 AM »

Model Number MODEL 250
Event Date 11/21/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

Event Description
It was reported that the physician's handheld is unresponsive to the stylus. It was reported that troubleshooting found that the handheld only responds to the stylus every 3rd tap. The physician was sent a new programming tablet and the handheld was received for analysis. Analysis is underway, but has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528587
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dennis100
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« Reply #241 on: December 26, 2018, 12:01:52 PM »

Model Number MODEL 250
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013, the physician reported that the handheld was not responding really well to taps. A hard reset was performed, and then the screen became stuck on the screen that gives the choices "set time" or "continue". It was noted that none of these choices were responding to his taps. When he did the reset, the screen just went out and came to this screen. During the reboot, the screens asking to copy and paste the appointment and the alignment screen did not appear. The manufacturer's representative got to the alignment screen and tapped on the crosshair that moved around on the screen. He said he tapped more than 10 times and didn't progress. Confirmed that he was using a stylus and tapping in the middle of the crosshairs. It would not progress even after so many taps. The crosshair just went around and around the screen. Another hard reset was performed with the same results. Verified that the handheld was plugged in all the time, on a desk in a dry, cool area. There are no signs of damage to the handheld or screen and it is not dirty. The physician did not know when the issue first started. The handheld and flashcard were returned to the manufacturer and product analysis was performed. The back-up battery was removed. The back-up battery voltage with no load measured 486mv (nominal (b)(4)). This is an indication that the back-up battery has been depleted. The handheld device was powered using the returned ac power supply adapter with no observed anomalies. An attempt was made to perform the initial setup process, but it was unable to advance past the screen alignment utility. The crosshair would move in response to the screen taps, but the handheld software would not advance to the next setup utility. The handheld case was opened and it was identified that there was debris trapped between the display and handheld case. The debris was removed and the display cleaned. The handheld device was powered using the returned ac power supply adapter with no observed anomalies. The initial setup process was performed with no observed anomalies. The back-up battery indicator read 0% which is expected because the back-up battery will discharge if the unit is not supported by an external power source. Vns v8. 1 software was installed with no observed anomalies. Interrogation and diagnostic tests were performed successfully with no observed anomalies using the v8. 1 software and a 103 generator. The handheld¿s main battery was fully recharged successfully using the power supply adapter. The power button light on the hhd was amber and then later turned green giving the indication that the main battery was fully charged. Interrogation and diagnostic tests were performed successfully with no observed anomalies using a 102 generator. The handheld was powered-on continuously using only the main battery for more than an hour. The handheld computer was powered-on continuously using only the main battery for more than an hour. For five successful times the following occurred: the generator was interrogated, then the output and magnet currents increased from 0ma to 0. 5ma, then interrogated to verify the new settings, then a generator diagnostic test was performed during which the generator values were changed back to output currents of 0 ma, and then the battery was interrogated to verify new settings. The main battery had a remaining charge of 75% at the conclusion of testing. An analysis was performed on the returned handheld and a cause for the reported allegation was verified. During the analysis it was identified that the handheld could not complete the screen alignment utility during the initial setup process. The cause for the anomaly is associated with debris that was trapped under the case. Once the display was cleaned, no further anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. The flashcard was returned with the allegation of no malfunction suspected/identified. No anomalies were identified via external inspection. V8. 1 software was installed and verified on the main screen with no anomalies. Interrogation and diagnostic tests were performed with no anomalies on a 103 generator. No anomalies were observed when diagnostic, parameter, and magnet history databases were viewed. For five successful times the following occurred: the generator was interrogated, then the output and magnet currents increased from 0ma to 0. 5 ma, then interrogated to verify the new settings, then a generator diagnostic test was performed during which the generator values were changed back to output currents of 0 ma, and then the battery was interrogated to verify new settings. Analysis performed on the returned flashcard determined that the allegation of no malfunction suspected/identified was verified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3519988
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dennis100
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« Reply #242 on: December 30, 2018, 06:09:33 AM »

Model Number MODEL 250
Event Date 12/19/2013
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld was at the align screen and keeps going "around and around". Troubleshooting was performed by a manufacturer employee. The battery was removed and reinserted, a hard reset was performed; however, the screen still continues to go "around and around". The edges of the screen were cleaned with a card and this did not resolve the issue. A new programming tablet was sent to the physician. The handheld is expected to be returned, but has not been received to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
The handheld device was returned to the manufacturer for analysis. Analysis of the returned handheld found that the cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3577154
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dennis100
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« Reply #243 on: January 11, 2019, 02:26:32 AM »

Model Number MODEL 250
Event Date 01/23/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the suspect medical device passed all functional tests prior to distribution.
 
Manufacturer Narrative
Corrected data: this information on follow-up mfr. Report #2 was inadvertently reported incorrectly. The date should have been reported as (b)(6) 2014 rather than 05/13/2014.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the handheld was frozen and a hard reset was performed. It was reported that the handheld would not progress from the screen alignment. It was reported that the alignment is done and the screen detects the taps, but the software requests to have the alignment performed again. A new programming computer was requested and the handheld was returned for analysis. The handheld analysis was completed on 07/07/2014. During the analysis it was identified that the handheld was unable to advance past the screen alignment utility due to resistance values being higher than expected in the touch screen circuitry. No further anomalies associated with the handheld performance were identified during the analysis. Analysis of the flashcard was completed on 07/07/2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
It was reported that physician was having issues with her programming system. Follow-up revealed that the physician¿s handheld device had a screen that would sometimes be unresponsive to the stylus. A new stylus was used, a hard reset was performed, the handheld was recalibrated, but this was unsuccessful in resolving the screen issues. Attempts for product return have been unsuccessful.
 
Event Description
Additional information was received stating that the handheld device was functioning properly with no issues; therefore, the product will not be returned. It was reported that a glitch may have occurred that caused the initial issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3772047
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dennis100
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« Reply #244 on: Today at 01:41:39 AM »

Model Number MODEL 250
Event Date 06/02/2014
Event Type  Malfunction   
Manufacturer Narrative
Serial #, lot #, other, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.
 
Manufacturer Narrative

Event Description
Product information was obtained. The handheld device has been returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution. Device failure occured, but did not cause or contribute to death or serious injury.
 
Event Description
Review of the device manufacturing records that the handheld device passed all functional tests prior to distribution. Product analysis on the returned handheld device was completed. It was identified that the handheld was unable to advance past the welcome screen. The cause for the display anomaly is associated with resistance values being higher than expected in the touch screen circuitry. Once the display was replaced with a known good display, no further anomalies associated with the handheld performance were identified during the analysis. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Event Description
It was reported that the screen and buttons on the handheld device were not responding. The handheld showed the alignment screen when powered on but was subsequently unresponsive. The edges of the screen were cleaned and a hard reset was performed, but the issue did not resolve. The handheld device has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3902233
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dennis100
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« Reply #245 on: Today at 01:42:40 AM »

Model Number MODEL 250
Event Date 06/11/2014
Event Type  Malfunction   
Event Description
Additional information was received clarifying that the handheld device had a frozen screen and was not responding to the user. The handheld device is expected to be returned to the manufacturer for analysis but has not been returned to date.
 
Manufacturer Narrative
Lot #, corrected data: previously submitted mdr incorrectly reported this information.
 
Event Description
It was reported that the physician's handheld does not respond to any command and has self behave. It is unknown if troubleshooting was performed. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the hospital staff was well trained in proper usage of the handheld. The handheld device was programmed off and intentionally returned with the lock button engaged.
 
Manufacturer Narrative

Event Description
The handheld and flashcard were received for analysis. Analysis of the handheld was completed on (b)(4) 2014. During the analysis it was identified that the handheld was received with the lock button in the locked position. Since the lock button was locked, the handheld buttons and touchscreen were unresponsive. Once the lock button was moved to the unlocked position no anomalies associated with the handheld performance were noted during testing using the ac adapter or the main battery with a full charge. Analysis of the flashcard was completed on (b)(4) 2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3892490
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