BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300

    MDR report key: 39965 · Received September 9, 1996

    Report

    Report Number
    8010042-1996-00008
    Event Type
    Malfunction
    Date Received
    September 9, 1996
    Date of Event
    August 12, 1996
    Report Date
    September 9, 1996
    Manufacturer
    SIEMENS-ELEMA AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR WAS CONNECTED TO A PT. THE CUSTOMER REPORTS THAT THE VENTILATOR'S FIO2 WAS SET TO 60%. AFTER THE PT WAS SUCTIONED THE FIO2 DROPPED TO 21% THEN GRADUALLY INCREASED TO 60%.

    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 * Required Intervention