BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE MPR MASK

    MDR report key: 35616 · Received August 15, 1996

    Report

    Report Number
    MW1009718
    Event Type
    Malfunction
    Date Received
    August 15, 1996
    Manufacturer
    HOSPITAK, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    CUSHION SEALED MANUAL RESUSCITATION MESH DEFLATES OVER TIME WHICH RENDERS MASK INOPERABLE IF NOT REINFLATED. DESIGN OF MASK WITH PLASTIC PLUG INSTEAD OF A ONE WAY VALVE COULD HAVE POTENTIAL FOR ADVERSE EVENT AT TIME OF A RESUSCITATION EMERGENCY. MFR RECOMMENDATION IS TO REINFLATE MASK PERIODICALLY. ALSO WHEN MASK DEFLATES, THE CUSHION SEAL MATERIAL BREAKS DOWN INTO A POWDERY SUBSTANCE AND RENDERS THE MASK INOPERABLE AND INCAPABLE OF REINFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE MPR MASK MANUAL PULMONARY RESUSCITATOR MASK BTM HOSPITAK, INC. MPR *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO