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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)(4).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 device had liquid damage, motor and control system were defective, worn clutch and damaged hose therefore, the reported condition was confirmed.The assignable root cause was determined to be due to cleaning, sterilization and/or maintenance procedures were not followed.This was further defined as component damage caused by user error / abuse and possibly misuse.If additional information should become available, a supplemental medwatch report will be sent 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 had damaged cable/cord/wiring.It was further noted that the device had liquid damage, defective motor and control system, worn clutch and damaged hose.It was noted in the service order that the device had an e6 cause error although it was left to cool down.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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