Model Number N/A |
Device Problems
Deflation Problem (1149); Leak/Splash (1354); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that during surgery, the device was leaking air.No adverse event is associated with this incident.There was no harm or injury to the patient.Due diligence is in progress with no response at this time.If additional information becomes available, a supplemental report will be completed and submitted.
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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.Initial reporter telephone number: (b)(6).
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under: (b)(4).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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It was reported that during surgery the device was 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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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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