Model Number MODEL 250 |
Device Problem
Battery Problem (2885)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
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 manufacturing records were reviewed.Review of manufacturing records of the handheld confirmed all quality tests were passed prior to distribution.
|
|
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 failure occurred, but did not cause or contribute to death or serious injury.
|
|
Search Alerts/Recalls
|