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Catalog Number EMAX2PLUS |
Device Problems
Device Inoperable (1663); Device Displays Incorrect Message (2591); Naturally Worn (2988)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Please note that the reporter's name, phone number, and email address were not provided.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 wear from normal use and servicing over time.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 by (b)(6) that the motor device displayed and e6 error code and the handpiece stopped working.During service and evaluation, it was noted that the device cable/cord/wiring was damaged.It was also noted that the device was displaying an e6 error, the control and the motor were defective, the hose was worn, and the input test was not possible.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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