DORNOCH 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); Failure to Power Up (1476)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/07/2023 |
Event Type
malfunction
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Event Description
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It was reported that the unit has no power and has a burnt cord.Event occurred outside of surgery.There was no reported patient harm, or delay.Due diligence is complete, no further information is available at this time.
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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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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 found to have no power and a burnt power cord.The power inlet module fuse was blown.There was evidence of dried fluids on the back on the unit toward the power inlet module.The power inlet module and wired power cord were replaced and resolved the reported issue.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.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.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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No additional event information is available.
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Search Alerts/Recalls
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