BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS MEDICAL SYSTEMS INC.

    MDR report key: 436876 · Received January 6, 2003

    Report

    Report Number
    MW1027184
    Event Type
    Injury
    Date Received
    January 6, 2003
    Date of Event
    January 2, 2003
    Report Date
    January 6, 2003
    Manufacturer
    SIEMENS MEDICAL SYSTEMS INC. ELECTROMEDICAL SYSTEMS DIVISION
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A SIEMENS SERVO VENTILATOR WAS CONNECTED TO A PT AND VENTING FOR SOME TIME. THE VENTILATOR STOPPED VENTING, ALARMS SOUNDED, AND THE PT HAD TO BE BAGGED TO SUSTAIN LIFE. A LOUD AIR-LEAKING NOISE WAS COMING FROM THE BACK OF THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS MEDICAL SYSTEMS INC. SERVOVENTILATOR 300 CBK SIEMENS MEDICAL SYSTEMS INC. ELECTROMEDICAL SYSTEMS DIVISION 300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening