Model Number N/A |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.
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Event Description
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It was reported that the device stops suddenly during testing on (b)(6) 2020.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).Review of the most recent repair record determined the rpms were in specification on the low end.The motor was replaced and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event cannot be confirmed.
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Search Alerts/Recalls
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