BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPACT INSTRUMENTATION INC

    MDR report key: 437133 · Received January 7, 2003

    Report

    Report Number
    437133
    Event Type
    Injury
    Date Received
    January 7, 2003
    Date of Event
    December 24, 2002
    Report Date
    January 6, 2003
    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 5 MALFUNCTIONED WHILE TRANSFERRING A PT FROM HOSPITAL TO HOSPITAL TRANSFER. WHILE ENROUTE TO THE HELI-PAD THE VENT STOPPED WORKING AND THE SYSTEM FAILURE LIGHT BEGAN FLASHING. THE VENT WAS IMMEDIATELY REMOVED FROM THE PT AND THE PT WAS VENTILATED WITH A BAG VALVE. THE PT DID NOT EXPERIENCE ANY DROP IN O2 SAT AS THE SWITCH WAS VERY QUICK. THE VENT WAS FREELY CHARGED & CHECKED PRIOR TO THE TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACT INSTRUMENTATION INC EAGLE VENT CBK IMPACT INSTRUMENTATION 754/744M *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening