BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS

    MDR report key: 430540 · Received November 26, 2002

    Report

    Report Number
    MW1026877
    Event Type
    Malfunction
    Date Received
    November 26, 2002
    Date of Event
    September 30, 2002
    Report Date
    November 26, 2002
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC. ELECTROMEDICAL SYSTEMS DIV.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SIEMENS SERVOVENTILATOR, LOCATED IN THE BIOMED SHOP DUE TO AN OXYGEN INPUT MODULE FAILURE THAT BURNED UP. UPON RECEIVING THE NEW REPLACEMENT OXYGEN INPUT MODULE FROM SIEMENS MEDICAL, HOSP INSTALLED IT INTO THE SERVOVENTILATOR, PLUGGED THE VENTILATOR INTO AC POWER AND TURNED IT ON. THE VENTILATOR STARTED VENTILATING MORMALLY. HOWEVER WITHIN A COUPLE OF MINUTES THE AIR INPUT MODULE STARTED SMOKING. QUICKLY TURNED THE MACHINE OFF AND UNPLUGGED IT FROM AC POWER. A NEW AIR INPUT MODULE WAS PURCHASED FROM SIEMENS AND INSTALLED. THE VENTILATOR WORKED PROPERLY WITH NO FURTHER PROBLEMS. THIS IS TWO CATASTROPHIC FAILURES OF THE INPUT MODULES SINCE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS PATIENT VENTILATOR CBK SIEMENS MEDICAL SYSTEMS, INC. ELECTROMEDICAL SYSTEMS DIV. 300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *