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Model Number BOXED PATIENT CIRCUIT ASSY, 3100A, 850S |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2021 |
Event Type
Injury
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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.The issue occurred with three patients.Please see (b)(4) for the other two.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, 850s (hose) came loose from the coupling piece that connects back to the humidification chamber of the f&p.As such, the hfo (high frequency oscillation) stopped.The hose was reinserted, fixed with brown tape, and secured with coupler and tie wrap.It happened during patient use but with no information regarding outcome.
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Manufacturer Narrative
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Device evaluation: according to the investigation and per samples sent by the customer we cannot determine a root cause since the id for tubing part number 29212-006 was dimensioned according to pqas.57-1024 etal and no issues were found, also the od for component part number mx65-4223a was dimensioned according to rmqas 3128a etal and no issues were found.Additionally the ifu part number 33571-001 included in the fg 29028-003 has the following note: "ensure all connections and fittings are hand tightened before use".Therefore, the root cause was undetermined.
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