BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE

    MDR report key: 3847300 · Received May 1, 2014

    Report

    Report Number
    3847300
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    February 10, 2014
    Report Date
    May 1, 2014
    Manufacturer
    CAREFUSION 211, INC.. DBA CAREFUSION
    Product Code
    BYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING MANUAL VENTILATION WITH AMBU BAG DURING TRANSPORT OF AN INTENSIVE CARE UNIT (ICU) PATIENT FROM EMERGENCY ROOM CT SCANNER TO MEDICAL INTENSIVE CARE UNIT (MICU), THE RESPIRATORY THERAPIST NOTICED THAT THE POSITIVE END EXPIRATORY PRESSURE (PEEP) VALVE DID NOT FIT AS TIGHTLY AS IT USED TO. THEN, THE PEEP VALVE FELL OFF OF THE AMBU BAG. THE PEEP VALVE WAS SET AT 15 CM H2O. THE PATIENT NEEDED CARDIOPULMONARY RESUSCITATION (CPR) IMMEDIATELY FOLLOWING THE LOSS OF THE PEEP VALVE. THE PATIENT WAS SUCCESSFULLY RESUSCITATED. LATER, THE RESPIRATORY THERAPY MANAGER FOUND OUT THAT THE PEEP VALVE HAD CHANGED, BUT THE DISTRIBUTOR AND CATALOG NUMBER WERE THE SAME (ENTIRELY DIFFERENT PEEP VALVE THAN PREVIOUSLY STOCKED PEEP VALVE). DISTRIBUTOR NEVER TOLD FACILITY ABOUT THIS CHANGE IN PEEP VALVE. A FORMAL COMPLAINT WAS LODGED WITH THE DISTRIBUTOR OVER THIS OVERSIGHT AND LACK OF COMMUNICATION. A FORMAL COMPLAINT WAS LODGED WITH CAREFUSION AS THERE WAS NO COMMUNICATION REGARDING THE CHANGE OF THE PEEP VALVE PRODUCT'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262201 AIRLIFE ATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE BYE CAREFUSION 211, INC.. DBA CAREFUSION 2K8080 131028

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR