BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERVO VENTILATOR

    MDR report key: 238028 · Received August 25, 1999

    Report

    Report Number
    MW1017069
    Event Type
    Other
    Date Received
    August 25, 1999
    Date of Event
    August 6, 1999
    Report Date
    August 20, 1999
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC.
    Product Code
    CBK
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE UNIT HAD BEEN ON PT FOR 1 HR. AFTER 1 HR WARM-UP APNEA ALARM SOUNDED AND UNIT "JUST QUIT". BIOMED TESTING CONFIRMS THAT IN THE SIMV AND PRESSURE MODES THE VENT'S DISPLAY JUMPED FROM THE SET NUMBER OF BREATHS (8) UP TO 20 AND THEN DOWN TO 4. APNEA ALARM COUNTS AND UNIT EVENTUALLY BREATHES AGAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other