Model Number AIRLIFE¿ ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2020 |
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.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 an issue on airlife¿ adult manual resuscitator, 40'' (1.0m) oxygen reservoir tubing, adult.Patient coded post procedure.The nurse started to bag the patient and the manual resuscitator failed to re-inflate after ventilation.Anesthesia arrived and noted the defect and they were able to establish the airway.The patient continued to be ventilated and eventually established spontaneous respirations.She was admitted over night for observation and was discharged home the following day.
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Manufacturer Narrative
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Vyaire medical conducted a failure investigation.The device history record (dhr) review did not show any deviations to manufacturer specifications.For functionality failure, it is imperative to receive a sample to duplicate the failure as described.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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The device history record of the p/n 2k8005 with lot number 0000322436 was reviewed in order to detect any issue related with the defect reported by the customer during its manufacturing.The complete lot was manufactured on 27may11 per our internal procedures and no issues were found.According to investigation, we determine manufacturing personnel are related with defect reported, since they must assemble these components inside of the component p/n 65-4213e with a manual press.In the samples received these components are disassembled.It possible manufacturing personnel did not do assembly properly and it provoked defect reported on this complaint.Personnel were retrained on spm 2k8000 etal.Some pictures of a correct assembly and an incorrect assembly were added as a reference on spm 2k8000 etal.This change was completed on (b)(6) 2020.
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Search Alerts/Recalls
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