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Catalog Number EMAX2PLUS |
Device Problems
Break (1069); Defective Device (2588); 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 found that the motor device cable/cord/wiring was damaged, the control unit was defective, the coupling was worn out, a closed hose and the ball bearings were sluggish.Therefore, the reported condition was confirmed.The assignable root cause was due to worn out components.This is further defined as wear from normal use and servicing over time.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 (b)(6) that during service and evaluation, it was observed that the motor device cable/cord/wiring was damaged.It was noted in the service order that "control unit defect, coupling worn out, closed hose and ball bearings sluggish".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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