BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMBU SPUR INFANT/CHILD RESUSCITATOR

    MDR report key: 347985 · Received August 22, 2001

    Report

    Report Number
    1220828-2001-00004
    Event Type
    Death
    Date Received
    August 22, 2001
    Date of Event
    August 10, 2001
    Report Date
    August 21, 2001
    Manufacturer
    AMBU INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN FULL CARDIAC ARREST. PT CONNECTOR OF SPUR INFANT/CHILD RESUSCITATOR WAS DEFORMED; ET TUBE CANNOT BE ATTACHED TO THE SPUR PT CONNECTOR. (HOWEVER, IF REQUIRED, PT COULD HAVE BEEN VENTILATED BY MASK.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38296 AMBU SPUR INFANT/CHILD RESUSCITATOR MANUAL SINGEL PT USE RESUSCITATOR BTM AMBU INC. * 2433373

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other