BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITAL SIGNS INC

    MDR report key: 371549 · Received January 10, 2002

    Report

    Report Number
    MW1023822
    Event Type
    Death
    Date Received
    January 10, 2002
    Date of Event
    January 7, 2002
    Report Date
    January 10, 2002
    Manufacturer
    VITAL SIGNS INC
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT 0713 PT WAS TAKEN OFF VENTILATOR TO TRANSPORT TO CARDIAC CATH LAB. RESUSCITATOR UTILIZED DURING TRANSPORT. UNPON ARRIVAL TO CATH LAB, PT PLACED ON VENTILATOR. AT 0725 PT'S CARDIAC RHYTHM AGONAL. CHEST COMPRESSIONS AND ACL'S PROTOCOL INITIATED. DURING CPR RESPIRATORY THERAPIST NOTICED NO RESISTANCE WITH AMBUBAG (RESUSCITATOR). PRESSURE CHECK PERFORMED ON DEVICE AND FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL SIGNS INC CODE BLUE II RESUSCITATOR BTM VITAL SIGNS INC 7550 E320

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| L