BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSPITAK

    MDR report key: 908488 · Received August 20, 2007

    Report

    Report Number
    908488
    Event Type
    Malfunction
    Date Received
    August 20, 2007
    Date of Event
    August 28, 2008
    Report Date
    August 30, 2007
    Manufacturer
    UNOMEDICAL INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH EPISODE OF RESPIRATORY ARREST-ATTEMPTED TO GIVE RESCUE BREATHS WITH PRODUCT-ONE WAY VALVE STUCK IN CLOSED POSITION. SECOND PRODUCT OBTAINED AND SAME MALFUNCTION OCCURRED. AMBUBAG OBTAINED AND PATIENT SUCCESSFULLY REVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPITAK RESUSCITATION MASK BTM UNOMEDICAL INC. 05-11

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR