BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300

    MDR report key: 46711 · Received September 19, 1996

    Report

    Report Number
    8010042-1996-00011
    Event Type
    Malfunction
    Date Received
    September 19, 1996
    Date of Event
    August 20, 1996
    Report Date
    September 18, 1996
    Manufacturer
    SIEMENS-ELEMA AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR WAS SET TO DELIVER 75% FIO2. THE VENTILATOR SPONTANEOUSLY DROPPED THE CONCENTRATION TO 60-62%. THE PT BEGAN TO DESATURATE AND THE FIO2 WAS INCREASED TO 100%. THE CONCENTRATION ROSE TO 85% AND STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO VENTILATOR 300 VENTILATOR CBK SIEMENS-ELEMA AB SV300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention