|
Catalog Number EMAX2PLUS |
Device Problems
Break (1069); Device Inoperable (1663); Defective Device (2588); Naturally Worn (2988)
|
Patient Problem
No Patient Involvement (2645)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Initial reporter 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 cable/cord/wiring was damaged and the coupling was worn out.It was further noted that the device did not work.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to misuse, abuse and/or use error.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 from (b)(6) that during service and evaluation, it was observed that the cable/cord/wiring was damaged on the motor device and the coupling was worn out.It was further reported that the motor and control were defective.It was noted in the service order that the device did not work.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
|
|
|