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Catalog Number EMAX2PLUS |
Device Problems
Moisture Damage (1405); 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 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.
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was discovered that the motor device had damaged component - cable/cord/wiring.It was further determined that there was liquid damage, the motor and control unit were defective, the connector pin cover, coupling, and the hose were worn out and the ball bearings were dirty.It was noted in the service order that the device did not work at all.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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Manufacturer Narrative
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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and found that the coupling was broken, became hot and machine was noisy.The assignable root cause was due to faulty and defective cleaning and maintenance, which is user error/misuse/abuse.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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