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 Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2023 |
Event Type
malfunction
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Event Description
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It was reported that outside of surgery the unit had water (fluid) intrusion on the power supply board.There was no patient involvement.Due diligence is complete and no additional information is available.At product evaluation investigation the power supply had a burnt spot.No adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under cmp-(b)(4).The investigation is complete.This is an initial final report submission.Review of the most recent repair record determined the unit was found to have saline that leaked onto the power cable and power inlet module.The power supply had a burnt spot.The power supply kit 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.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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