ZIMMER SURGICAL, INC. DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
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Model Number N/A |
Device Problems
Thermal Decomposition of Device (1071); Device Emits Odor (1425)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This event is recorded with zimmer biomet under (b)(4).This medwatch is being filed as an initial report.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that outside of surgery the unit smells like something is burning.It was determined the end of the cord showed signs of melting, power short, and charring.No report of smoke.There was no reported patient harm, or delay.Due diligence is complete, no further information is available at this time.
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Event Description
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No additional information is 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 unit was confirmed to have an odor and had a charred power cord at the wall plug end.From follow up with the service manager it was determined that the wall socket the cart was plugged into was not grounded properly.The power cord 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 an infrastructure 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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Search Alerts/Recalls
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