BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACT INSTRUMENTATION, INC.

    MDR report key: 553513 · Received November 1, 2004

    Report

    Report Number
    553513
    Event Type
    Malfunction
    Date Received
    November 1, 2004
    Date of Event
    October 26, 2004
    Report Date
    October 28, 2004
    Manufacturer
    IMPACT INSTRUMENTATION
    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

    CREW RAN A CALL WITH A PT ON A VENT. PT WAS BEING SENT TO NURSING HOME. PT WAS PUT ON VENT WHEN AN ALARM STATED TO CHARGE. IT WAS PLUGGED INTO UNIT. ALARM STATES HIGH PRESSURE/INSPIRATORY TO HIGH, READJUSTED SETTING WHICH CORRECT THE PROBLEM. ALARM WENT OFF AGAIN, SAYING DISCONNECT VENT PM IS DUE. THE ALARM SOUNDED AGAIN & SCREEN WENT OFF + ON AGAIN SHOWING VENT FAILURE DETECTED. CODE 2 EXTERNAL/INTERNAL O2 LOW.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other