|
Catalog Number 05.001.204 |
Device Problems
Failure to Power Up (1476); Battery Problem (2885); Device Operates Differently Than Expected (2913); Failure of Device to Self-Test (2937)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Initial reporter¿s phone number: (b)(6).) this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and observed that the universal battery charger device had a flashing blue led and failed self test.Therefore, the reported condition was confirmed.However, an assignable root cause was not determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported by (b)(6) that during service and evaluation, it was observed that the universal battery charger device had a flashing blue led and failed self test.It was noted in the service order that the orange lamp did not turn on when the battery was inserted but it illuminated the blue lamp all the time.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|