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Model Number BOXED PATIENT CIRCUIT ASSY, 3100A, 850L |
Device Problem
Material Too Soft/Flexible (4007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Vyaire medical file identification:(b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.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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The customer reported that the boxed patient circuit assy, 3100a, 850l is extremely pliable and bend which obstructs the flow on the oscillator and often stops it from working.The issue is often associated with the tubing that is connected to the humidifier.The customer stated that they have had 5 of the same issue.The oscillator turned off and they tried to restart it but to no avail.They called in a member of the staff who noticed that a part was popped off by the humidifier.They called tech team, put the tubing back on and placed a tape over the tubing to keep it in place.There is no patient information.
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Search Alerts/Recalls
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