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Catalog Number 530.610 |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to normal wear.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Event Description
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It was reported that during pre-surgery, it was observed that the battery oscillator device was frozen and not oscillating.During in-house engineering evaluation, it was determined that the unit was running intermittently and had worn and damaged wires on the electronic control unit.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 available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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