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Catalog Number 530.200 |
Device Problem
Power Conditioning Problem (1474)
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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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Event Description
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It was reported from (b)(6) that the battery drive device has power issues.It was not reported that the malfunction occurred during surgery.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of the 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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Manufacturer Narrative
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(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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