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
No Display/Image (1183); Smoking (1585); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/02/2023 |
Event Type
malfunction
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Manufacturer Narrative
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This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete 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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It was reported that outside of surgery the unit got wet, and smoke was coming from the unit.The display showed communication error and then went blank.There was no harm or delay reported.No adverse events were reported as a result of this malfunction due diligence is in progress.No further information is available at this time.
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Manufacturer Narrative
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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.Review of the most recent repair record determined the unit was found to have a burnt display cable.The display cable and control board 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.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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There is no additional event information available.
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