BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT INSTRUMENTATION INC.

    MDR report key: 428223 · Received November 12, 2002

    Report

    Report Number
    428223
    Event Type
    Injury
    Date Received
    November 12, 2002
    Date of Event
    November 6, 2002
    Report Date
    November 7, 2002
    Manufacturer
    IMPACT INSTRUMENTATION
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    VENT 7 EAGLE MALFUNCTIONED WHILE ON A CALL WITH A PT'S SEIZURE. PT BEING TRANSFERED FROM HOSPITAL TO HOSPTIAL. VENT 7 WAS CONNECTED TO PT AND SET OFF AN ALARM ADVISING OF BATTERY LOW/FAIL ON THE SCREEN. APPROX. 15 SEC. LATER THE VENT WENT INTO SYSTEM FAILURE AND SHUTDOWN. THERE WAS NO PT COMPROMISE DUE TO PT IMMEDIATELY BEING TRANSFERED TO A "BVM".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening