BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SV300

    MDR report key: 358309 · Received October 25, 2001

    Report

    Report Number
    8010042-2001-00218
    Event Type
    Malfunction
    Date Received
    October 25, 2001
    Report Date
    October 22, 2001
    Manufacturer
    SIEMENS-ELEMA AB/LIFE SUPPORT SYSTEMS DIVISION
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVEN GAS MODULES GIVEN TO THE COMPANY BY THE CUSTOMER. THESE MODULES HAD FAILED OVER A PERIOD OF TIME AND WERE GIVEN TO THE COMPANY BY THE CUSTOMER FOR FAILURE ANALYSIS. NO PATIENT INVOLVEMENT IS REPORTED. MODULE #1-6 FAILURE FOUND COIL L1 BURNED. MODULE #7 FAILURE FOUND DEFECTIVE CURRENT-SERVO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47990 SV300 RESPIRATORY VENTILATOR CBK SIEMENS-ELEMA AB/LIFE SUPPORT SYSTEMS DIVISION NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other