DORNOCH DUO FLUID CART WITH POWER IV; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
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Model Number N/A |
Device Problems
Thermal Decomposition of Device (1071); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/10/2023 |
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 the unit has a leaking receiver and burned power inlet module.No further info.There was no patient involvement.No adverse events were reported as a result of this malfunction.No further information is available at this time.
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Event Description
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No additional information 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 burned power inlet module, leaking receiver, and loose iv pole.Power inlet module and receiver were replaced, iv pole bracket tightened, and resolved the reported issue.Sw v2.1 installed.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 device design.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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Search Alerts/Recalls
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