Model Number N/A |
Device Problems
Deflation Problem (1149); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.
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Event Description
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It was reported that during pre-op testing, the device was leaking air.There is no adverse event associated with this incident.Due diligence is in progress with no response as of yet.If additional information becomes available, a supplemental report will be completed and submitted.
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Event Description
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It was reported that during testing, the device is leaking air and spontaneously deflated.The device was brand new.The patient was under anesthesia during the 0-15 minute delay.Due diligence is complete and there is no additional information available.No adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).Following sections were updated or corrected: if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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This device did not cause or contribute to serious injury.Therefore this is not reportable; the initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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This device did not cause or contribute to serious injury.Therefore this is not reportable; the initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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