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Catalog Number EMAX2PLUS |
Device Problems
Break (1069); Component Missing (2306); Defective Device (2588); Naturally Worn (2988); Torn Material (3024)
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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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Upon further review of the complaint, it was determined that the reported malfunction is unlikely to cause or contribute to serious injury or death if it were to recur.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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Manufacturer Narrative
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Initial reporter number: (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 from (b)(6) that during service and evaluation, it was observed that the motor device had damaged component - cable/cord/wiring.It was further determined that the motor and control system were defective, outer duct was damaged, leader pin was missing and the coupling was worn.It was noted in the service order that the device did not work at all and the hose was torn.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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