Model Number AIRLIFE¿ ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 03/12/2021 |
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.No root cause has 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 airlife¿ adult manual resuscitator, 40'' (1.0m) oxygen reservoir tubing, adult mask experienced patient ambu bag was not seeming to fill with air or there was no resisting of the bag.Patient o2 saturation dropped.As an intervention, different ambu bag was used.
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Manufacturer Narrative
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Result of investigation: the physical sample was received.Found broken defect on the component.According to the investigation, root cause was undetermined but the damage in the unit provided could be attributed to misuse by the customer.
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Search Alerts/Recalls
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