BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 809885 · Received October 18, 2005

    Report

    Report Number
    1217052-2005-00093
    Event Type
    Malfunction
    Date Received
    October 18, 2005
    Date of Event
    September 1, 2005
    Report Date
    September 22, 2005
    Manufacturer
    GALEMED CORPORATION, ASD, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THAT HAD ONE EVENT OF A RESUSCITATOR FACE MASK NOT BEING PROPERLY INFLATED AND COULD NOT BE SEALED ON THE PT'S FACE. ANOTHER MASK WAS OBTAINED AND NO ADVERSE OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, ADULT MANUAL RESUSCITATOR SYSTEM BTM GALEMED CORPORATION, ASD, INC. NA 040412

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO