BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS

    MDR report key: 369987 · Received December 18, 2001

    Report

    Report Number
    369987
    Event Type
    Malfunction
    Date Received
    December 18, 2001
    Date of Event
    December 14, 2001
    Report Date
    December 17, 2001
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC. MEDICAL DIV. LIFE SUPPORT SYSTEMS PRODUCTS
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPY IN ROOM WITH PT AND NOTICED A SMELL COMING FROM VENTILATOR. CHANGED OUT THE VENTILATOR. 30 MINS LATER THE VENTILATOR STARTED SMOKING A LITTLE. P.M. DONE IN 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57181 SIEMENS ADULT VENTILATOR (SERVO) CBK SIEMENS MEDICAL SYSTEMS, INC. MEDICAL DIV. LIFE SUPPORT SYSTEMS PRODUCTS SIEMENS 300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other