BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300

    MDR report key: 39670 · Received September 5, 1996

    Report

    Report Number
    8010042-1996-00007
    Event Type
    Malfunction
    Date Received
    September 5, 1996
    Date of Event
    August 9, 1996
    Report Date
    September 5, 1996
    Manufacturer
    SIEMENS-ELEMA AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM WAS ISOLATED TO A BAD DC/DC CONVERTER ON THE PC 1618 BOARD.

    Description of Event or Problem · 1

    THE VENTILATOR OPERATED ERRATICALLY, THE FRONT PANEL LIT UP (VARIOUS LED'S AND MESSAGES), THEN STOPPED CYCLING.

    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