BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACT INSTRUMENTATION INC.

    MDR report key: 617235 · Received June 21, 2005

    Report

    Report Number
    617235
    Event Type
    Malfunction
    Date Received
    June 21, 2005
    Date of Event
    June 14, 2005
    Report Date
    June 15, 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 ON A VENT TRANSPORT FROM HOSPITAL TO HOSPITAL. REPORTER WAS 9 MIN. FROM DESTINATION WHEN VENT ALARMED TOTAL SYSTEM FAILURE. PATIENT WAS IMMEDIATLY BAGGED WITH A BVM. THERE WERE NO INCIDENT WITH PATIENT AND PATIENT WAS HANDED TO THE HOSPITAL STAFF WITH 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 52 YR Other