BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CARE

    MDR report key: 672106 · Received January 26, 2006

    Report

    Report Number
    MW1037848
    Event Type
    Malfunction
    Date Received
    January 26, 2006
    Date of Event
    January 21, 2006
    Report Date
    January 26, 2006
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CODE BLUE PRESENTED AT ER. WHEN TAKING PRODUCT OUT OF CART AND OPENED, KIT INCOMPLETE BECAUSE THERE WAS NO MASK ON THE AMBU KIT, NECESSITATING LOCATING A DIFFERENT KIT FROM ANOTHER ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CARE ADULT RESUSCITATOR BTM VENTLAB CORPORATION VN1003MC 61054

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other