BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMBU SPUR

    MDR report key: 26957 · Received July 20, 1995

    Report

    Report Number
    MW4000703
    Event Type
    Death
    Date Received
    July 20, 1995
    Date of Event
    February 6, 1995
    Report Date
    March 12, 1995
    Manufacturer
    AMBU, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS FOUND IN AT 6:20 AM ON 2/6/95 IN CARDIAC ARREST IN AN IN-PATIENT PSYCHIATRIC UNIT. HOSP POLICE RESPONDED WITH EQUIPMENT FROM POLICE CAR. A BAG VALVE MASK OBTAINED FROM POLICE DUFFEL BAG HAD BEEN PACKED IN RECOMMENDED MANNER TO MAKE DEVICE COMPACT, WITH BAG FOLDED ON ITSELF. THE DEVICE WAS FROZEN SUCH THAT IT WAS STUCK TOGETHER, & COULD NOT BE USED. THE AIR TEMPERATURE THAT EVENING WAS APPROX 0 DEGREE F. MFR RECOMMENDS STORAGE UP TO -40 DEGREES C. THIS RESULTED IN DELAY OF 10 TO 20 SECONDS. WHILE THIS DID NOT CAUSE THE PT'S DEATH, THIS NEEDS TO BE REVIEWED TO PREVENT ANY PROBLEMS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU SPUR BAG VALVE MASK BTM AMBU, INC. 420-911-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death CIRCLE SEAL MASK MFG BY RESPIRONICS, INC.