BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 965344 · Received November 8, 2006

    Report

    Report Number
    1217052-2006-00090
    Event Type
    Malfunction
    Date Received
    November 8, 2006
    Date of Event
    October 16, 2006
    Report Date
    October 24, 2006
    Manufacturer
    MFG BY SMITHS MED ASD, INC. BY: GALE MED CORP
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THEY WERE UNABLE TO GET A SEAL WITH THE MASK DUE TO THE MASK CUSHION SEPARATED FROM THE CONE. ALLEGEDLY HAD SEVERAL UNITS WITH THE MASK EITHER SEPARATED AT CONE OR WITH A HOLE IN THE CUSHION. FOUND DURING TRAINING SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, ADULT 73 BTM - MANUAL RESUSCITATOR SYSTEM BTM MFG BY SMITHS MED ASD, INC. BY: GALE MED CORP * 051114

    Patients

    Seq Age Sex Outcome Treatment
    1 *