BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULMONARY EXERCISE SYSTEM

    MDR report key: 17951 · Received November 23, 1994

    Report

    Report Number
    MW1004123
    Event Type
    Malfunction
    Date Received
    November 23, 1994
    Date of Event
    October 27, 1994
    Report Date
    November 10, 1994
    Manufacturer
    WARREN E. COLLINS, INC.
    Product Code
    BWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    OPERATOR WAS CALIBRATING SYSTEM BEFORE EXERCISE TEST. THE CALIBRATION GAS TANK WA EMPTY AND HAD TO BE CHANGED. TANK WAS CHANGED AND CALIBRATION RESTARTED. DURING COOLING PERIOD OPERATOR HEARD A DIFFERENT SOUND THAN NORMAL. JUST BEFORE SHE GOT TO THE BACK OF THE UNIT, ONE OF THE WATER BATH HUMIDIFYING CYLINDERS EXPLODED, SENDING PIECES OF PLEXIGLASS ACROSS THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULMONARY EXERCISE SYSTEM PULMONARY EXERCISE SYSTEM BWF WARREN E. COLLINS, INC. CPXIII

    Patients

    Seq Age Sex Outcome Treatment
    1 *