Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV |
Device Problem
Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On 1/25/2024 it was reported by a facility representative via (b)(4) that an ar-6480 dualwave arthroscopy fluid management system has a pump pressure fault.This was discovered during a procedure.The patient was not affected.The issue was resolved by performing maintenance to confirm the functionality of the pump, which passed all the tests.
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Search Alerts/Recalls
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