DORNOCH DUO FLUID CART WITH POWER IV, REFURBISHED; 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 09/05/2023 |
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, the unit had no power, and the ac cord has burnt mark.The power inlet module was not damaged.The unit had physical evidence of burn.The account did not have the cart plugged into a power strip or extension cord.There was no patient involvement.Due diligence is complete, no further information is available.
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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 unit was confirmed to not power on.The power inlet module was found to have melted and showed signs of bubbling and the power cord was burnt.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 of the reported issue is attributed to a 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 blown fuses 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 the fuse has blown or fuse drawer deformation.Therefore, zimmer biomet will not be reporting this failure mode going forward.
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Event Description
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There is no additional information available.
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Search Alerts/Recalls
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