BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACT INSTRUMENTATION, INC.

    MDR report key: 589614 · Received April 8, 2005

    Report

    Report Number
    589614
    Event Type
    Malfunction
    Date Received
    April 8, 2005
    Date of Event
    April 4, 2005
    Report Date
    April 5, 2005
    Manufacturer
    IMPACT INSTRUMENTATION, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    WHILE RUNNING A HOSPITAL TO HOSPITAL TRANSFER. THEY HAD A PT ON A VENT. PT WAS TRANSFERRED AND CONNECTED TO A PORTABLE VENT. PT WAS LOAD INTO AMBULANCE IS WHICH THE O2 WAS SWITCHED FROM PORTABLE TO THE MAIN 02. THE VENT THEN ALARMED -WITH-FALSE ERROR AND GAVE CODE FOR MAJOR MALFUNCTION. NO AIR COMING OUT OF VENT. THE TIDAL VOLUME WAS SET ON 420, WITH NO OUTPUT, THEN VENT STARTED PUTTING OUT 39 TIDAL VOLUME. PT WAS BAGGED WITH BVM. PT SUFFERED NO COMPROMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT INSTRUMENTATION, INC. MODEL 754 EAGLE VENT CBK IMPACT INSTRUMENTATION, INC. EAGLE VENT 754 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other