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Catalog Number EMAX2PLUS |
Device Problems
Break (1069); Defective Device (2588); Device Operates Differently Than Expected (2913)
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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 observed that the device had damaged component, locking component and noted that the clutch/lock was defective.It was also noted that the device failed the pre-repair assessement for safety.The device was evaluated and found to be powerbroken as it would not turn off/unintended motion.Therefore, the reported condition was confirmed.It was determined that this was due to running the device in the safe or load position.The assignable root cause was determined to be due to user error and abuse/misuse of the device.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 locking components and the clutch/lock was defective.It was also noted that the device failed the pre-repair assessement for safety.The device was evaluated and found to be powerbroken as it would not turn off/unintended motion.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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