Catalog Number 05.001.204_DL |
Device Problems
Thermal Decomposition of Device (1071); Device Emits Odor (1425); Overheating of Device (1437); Noise, Audible (3273)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 that the universal battery charger device made a popping noise and smelled like something was burnt inside.The event was reported to have occurred at the office.There was no patient involvement reported.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.
|
|
Manufacturer Narrative
|
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the device presented a short circuit to the power supply line.It was determined that the power supply was not functioning and was defective.It was further determined that the device was damaged due to improper handling, most probably due to a fall.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due improper handling, which is user error/misuse/abuse.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|