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Catalog Number EMAX2PLUS |
Device Problems
Break (1069); Defective Device (2588); Device Displays Incorrect Message (2591)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/05/2014 |
Event Type
malfunction
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Manufacturer Narrative
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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 was confirmed.The assignable root cause was determined to be due to faulty cleaning and maintenance of the device.This is further defined as misuse, abuse, and possible 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 from (b)(6) that during service and repair, it was observed that the motor device had a damaged cable/cord/wiring, a defective motor and controller, and an e6 error.This event was not related to surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.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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