BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBU SPUR II ADULT RESUSCITATOR

    MDR report key: 1590958 · Received January 26, 2010

    Report

    Report Number
    MW5014569
    Event Type
    Malfunction
    Date Received
    January 26, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 26, 2010
    Manufacturer
    AMBU A/S
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEWLY OPENED AMBU BAY EMPLOYED TO INTUBATED SPONTANEOUSLY BREATHING PT. DELIVERED O2 SO SATS ADEQUATE BUT DID NOT RECALL PROPERLY. USER WAS DR (B) (6) ADVISED PURCHASING OF THIS EVENT FOR TRACKING PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU SPUR II ADULT RESUSCITATOR BTM AMBU A/S 1074331

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR