BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACT INSTRUMENTATION INC.

    MDR report key: 656465 · Received December 21, 2005

    Report

    Report Number
    656465
    Event Type
    Malfunction
    Date Received
    December 21, 2005
    Date of Event
    December 7, 2005
    Report Date
    December 20, 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

    WAS TRANSFERING A PT FROM ONE HOSP TO ANOTHER. SET VENT TO CORRECT TIDAL VOLUME ENROUTE TO HOSP, WHILE ENROUTE VENT STOPPED DELIVERING TIDAL VOLUME. VENT WAS RESET WITH NO CHANGE. PT WAS THEN BAGGED.

    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 34 YR Other