BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO MECHANICAL VENTILATOR

    MDR report key: 83766 · Received April 15, 1997

    Report

    Report Number
    MW1011136
    Event Type
    Malfunction
    Date Received
    April 15, 1997
    Date of Event
    March 26, 1997
    Report Date
    March 31, 1997
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC. ELECTROMEDICAL GRP.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    VENTILATOR IN USE ON PT. INSPIRATORY PAUSE BUTTON DEPRESSED AND BOTH AIRWAY PRESSURE AND VOLUME METERS WENT TO O. VENTILATOR STOPPED DELIVERING BREATHS. RN REMOVED PT FROM VENTILATOR AND VENTILATED WITH MANUAL RESUSCITATOR WITH O2 AT FLUSH. RN PLACED PT ON ANOTHER VENTILATOR. NI UNTOWARD PT EFFECTS. REP THEN IN ATTENDANCE THROUGHOUT. ACTION TAKEN BY DISTRIBUTOR. THE UNIT RECEIVED AN OPERATIONAL VERIFICATION PROCEDURE. ALL TESTS WERE PASSED. WHILE THE UNIT WAS RUNNING THE INSPIRATORY AND EXPIRATORY PAUSE BUTTONS DEPRESSED SEVERAL TIMES. THE PROBLEM COULD NOT BE DUPLICATED. DISTRIBUTOR THEN CONTACTED MFR ABOUT THE INCIDENT. MFR BELIEVES THE PROBLEM WAS CAUSED BY THE INSPIRATORY PAUSE BEING STUCK. THE BUTTON ASSEMBLY WAS DISASSEMBLED AND EXAMINED FOR DAMAGE, AND WAS FOUND TO BE WORKING PROPERLY. THE CIRCUIT BOARD ASSEMBLIES WERE THEN CHECKED FOR LOOSE CONNECTIONS. THE UNIT WILL NOW BE RUN FOR 24 HRS WHILE PERIODICALLY CHECKING THE INSPIRATORY AND EXPIRATORY PAUSE BUTTONS. THE UNIT MEETS MFR'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO MECHANICAL VENTILATOR SERVO MECHANICAL VENTILATOR CBK SIEMENS MEDICAL SYSTEMS, INC. ELECTROMEDICAL GRP. SERVO 900C *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other