VYAIRE MEDICAL INC. BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L; VENTILATOR, HIGH FREQUENCY
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Model Number BOXED PAT CIRCUIT ASSY,3100A,FLTRD,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 06/03/2022 |
Event Type
Injury
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Event Description
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The customer reported that the plastic in which the boxed pat circuit assy, 3100a, fltrd, 850l is made from is not sufficiently rigid for its purpose.They have a child that is being treated with the 3100a for 2.5 days, and the circuit/hose has a cable tie in place to make it leak tight.The circuit is warm, and the plastic feels much softer that it did when it was set up, which maybe the reason it is not gripping the connector properly.No harm is associated with the event.
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Manufacturer Narrative
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At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.
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Manufacturer Narrative
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H3: 81: other- the suspect device is not available for return, as it was discarded after the treatment.Sample photo was evaluated and confirmed the reported issue.It was determined that manufacturing personnel may be related with the reported defect since the spm 11518-16vs etal states that the correct method to package the fg is by making a clockwise circle with the heated wire and then a another circle against clockwise with the circuit body, and lastly introducing the other components inside the bag.If personnel do not follow these instructions correctly, the type of defect reported in this complaint may occur.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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