DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
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Model Number N/A |
Device Problems
Fluid/Blood Leak (1250); 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 03/31/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.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 the cart's power inlet module was smoking, had a red screen communication error, and was leaking fluid before surgery while setting up for a case.The event occurred prior to surgery.There was no patient harm.The cart was removed before patient was brought in.
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Event Description
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No additional event information available.
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the cart would not power on via wall outlet.The power inlet module and fuse on the 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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Search Alerts/Recalls
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