Model Number N/A |
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 10/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Once the investigation is complete, a follow up/final report will be submitted.(b)(6).
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Event Description
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It was reported that the devices had been stopping for days and at the end it has stopped.No adverse events were reported as a result of this malfunction.
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Event Description
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There is no additional information.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the motor speed was not stable and unit was out of calibration and the motor and bearings were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
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Search Alerts/Recalls
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