DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
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Model Number N/A |
Device Problems
Thermal Decomposition of Device (1071); Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2023 |
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 outside of surgery, that the unit would not power on.The power inlet was burnt, and the unit had evidence of charring.There was no patient involvement.Due diligence is complete, there is no further information available.
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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 power inlet module was replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The root cause is attributed to component failure.The event is confirmed.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.Upon review of our reporting decision on burn/char exhibiting signs of overheating.A review of all complaints for this product indicates that there has never been an event that has resulted in a death, serious injury, and/or actual fire when there are only signs of burn and/or char.Therefore, zimmer biomet will not be reporting this failure mode going forward.
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Event Description
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No adverse events were reported as a result of this malfunction.No additional event information available.
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Search Alerts/Recalls
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