Model Number CIRCUIT RESP PED 4FT UNHTD 20/CS |
Device Problem
Failure to Disconnect (2541)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluated by mfr: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, it was confirmed that the customer changed the circuit to prevent patient injury/harm.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Event Description
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It was reported to vyaire medical that the water trap was difficult to remove from the 9076-701 circuit resp ped 4ft unhtd 20/cs.The event occurred during use.The customer confirmed that there was no patient harm associated with the reported event.
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Manufacturer Narrative
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H3: a video was provided from the customer for the investigation.Vyaire's investigation team could see the infant circuit that had the rigid water trap was difficult to disassemble.Therefore, the defect reported by the customer was confirmed.Since the physical sample is required to perform an investigation, a root cause could not be determined at this time.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56, if additional information becomes available.
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Manufacturer Narrative
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Vyaire medical's investigation team was able to confirm the reported issue.When the investigation team attempted to disassemble the water trap it was hard to seperate the body float water trap and the tank float water trap.Therefore, a quality notification was sent to the supplier of both components for further investigation.No defects were found on the sample received and the root cause of the failure was undetermined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56, if additional information becomes available.
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Search Alerts/Recalls
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