BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACT INSTRUMENTATION INC.

    MDR report key: 628796 · Received August 18, 2005

    Report

    Report Number
    628796
    Event Type
    Malfunction
    Date Received
    August 18, 2005
    Date of Event
    August 12, 2005
    Report Date
    August 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

    PT WAS PUT ON VENT FOR A GROUND TRANSPORT TO ANOTHER HOSPITAL. PT WAS ON 80% O2 VENT WAS GIVING ALARM. CONTACTED FTO AND PROBLEM WAS RESOLVED. WHILE LOADING PT THE ALARM STARTED GOING OFF AND SCREEN SHOWED SYSTEM FAILURE AND SHUT DOWN. TURNED VENT BACK ON AND WORKED AGAIN FOR 20 SEC AND THE SCREEN BLINKED AND AGAIN SHOWED SYSTEM FAILURE PT WAS THEN BAGGED WITH NO COMPROMISE AND HAD AIRMED 5 TRANSPORT PT.

    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 46 YR Other