BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300

    MDR report key: 460949 · Received May 16, 2003

    Report

    Report Number
    8010042-2003-00132
    Event Type
    Malfunction
    Date Received
    May 16, 2003
    Date of Event
    March 25, 2003
    Report Date
    May 16, 2003
    Manufacturer
    SIEMENS-ELEMA AB/LIFE SUPPORT SYSTEMS DIVISION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE SV300 COMES TO NORMAL SERVICE. THE SERVICE PARTS WERE CHANGED AND THE SV300 WAS WARMING UP. SUDDENTLY SMOKE COMES OUT OF THE VENTILATOR, AND THE TECHNICIAN SHUTS DOWN THE EQUIPMENT. THREE COMPONENTS BROKE: 1) PC BOARD 1618 (P/N 6038702) PC BOARD 1585 + 1586 (P/N 6150143) 3) EXP. VALVE COMPL. (P/N 6040005).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO VENTILATOR 300 RESPIRATORY VENTILATOR CBK SIEMENS-ELEMA AB/LIFE SUPPORT SYSTEMS DIVISION SERVO VENTILATOR 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA