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Catalog Number 530.710 |
Device Problem
Unintended System Motion (1430)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition was not confirmed.However during evaluation, it was noted that the device bearing was worn, had unintended motion and had low power.It was further determined that the device failed pretest for check for unintended motion and check oscillation frequency with frequency meter.The assignable root cause was traced to component failure due to normal wear.Udi: (b)(4).
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the battery oscillator device bearing was worn, had unintended motion and had low power.It was further determined that the device failed pretest for check for unintended motion and check oscillation frequency with frequency meter.It was noted in the service order that the device was not working.This event did not occur during 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 will be submitted accordingly.
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Search Alerts/Recalls
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