Model Number AF1100MBS |
Device Problems
Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
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Patient Problems
Not Applicable (3189); Missing Value Reason (3192)
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Event Date 09/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The customer alleges that there was no valve or manometer in the bag." no other details were provided and no patient injury/harm reported.The affected device was not returned.Samples of the product were visually inspected from inventory all were confirmed with a manometer/valve attached to the bag and all components were present.The batch record was reviewed and there were no non-conformances.
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Event Description
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The customer alleges that " when ambu bag was opened it had the mask and bag, but no valve or manometer attached." no other details were provided and no patient injury/harm reported.
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Manufacturer Narrative
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Affected product was returned.The returned product was evaluated, and the missing patient valve with manometer was confirmed.All inventory is tested in line to ensure it functions before it is packaged.A bag missing the patient valve and manometer would be obvious to manufacturing personnel.A nonconformance has been opened to further investigate this defect.
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Event Description
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The customer alleged that "when ambu bag was opened it had the mask and bag, but no valve or manometer attached." no other details were provided and no patient injury/harm reported.
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Search Alerts/Recalls
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