BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTLAB V CARE 1000 SERIES

    MDR report key: 590479 · Received April 6, 2005

    Report

    Report Number
    2246980-2005-00002
    Event Type
    Malfunction
    Date Received
    April 6, 2005
    Report Date
    April 4, 2005
    Manufacturer
    VENTLAB CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THEPATIENT INTUBATION, WHILE REMOVING THE MASK FROM THE RESUSCITATOR BAG, THE 15MM PATIENT ADAPTOR BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTLAB V CARE 1000 SERIES RESUSCITATION BAG BTM VENTLAB CORPORATION VN1000MB 4020-49

    Patients

    Seq Age Sex Outcome Treatment
    1 *