BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACT INSTRUMENTATION INC.

    MDR report key: 619679 · Received June 30, 2005

    Report

    Report Number
    619679
    Event Type
    Malfunction
    Date Received
    June 30, 2005
    Date of Event
    June 28, 2005
    Report Date
    June 29, 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

    TWENTY MINUTES INTO TRANSPORTING VENT' PATIENT THE VENT FAILED. THE SYSTEM FAILURE LIGHT CAME ON AND THE SCREEN WENT BLANK . PATIENT WAS IMMEDIATELY BAGGED AND PFS, FTO NOTIFIED AT DESTINATION OF INCIDENT.

    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 58 YR Other