Model Number N/A |
Device Problems
Fluid/Blood Leak (1250); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under cmp-(b)(4).Once the investigation 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 fan spray kit didn't work when the surgeon turned on the switch.Surgeon found battery leakage when he opened battery pack.The surgeon used another product.There was no harm, no delay, and no medical intervention.No adverse events have been reported as a result of the malfunction.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Visual examination of the returned product/provided pictures identified the device was returned opened, unused in the original tyvek tray.Visual inspection of the interior of the battery pack found one of the batteries had leaked inside the pack.No other damage was found.Functional testing found the device powered on and functioned normally when connected to the lab battery pack.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
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Event Description
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There is no additional information.
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Search Alerts/Recalls
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