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Catalog Number EMAX2PLUS |
Device Problems
Defective Device (2588); Device Displays Incorrect Message (2591); Naturally Worn (2988)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The device was returned for service however did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition that was confirmed.The assignable root cause was to be component damage caused by misuse, abuse, and/or user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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It was reported by switzerland that during service and evaluation it was observed that the cable/cord/wiring was damaged on the motor device.It was further observed that the motor and control system were defective, and the hose and coupling were worn.It was noted in the service order an e6 error.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.
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Search Alerts/Recalls
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