BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE

    MDR report key: 5210911 · Received November 9, 2015

    Report

    Report Number
    2112667-2015-00212
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    September 3, 2015
    Report Date
    November 5, 2015
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOURCE OF REPORT IS USER FILED MEDWATCH MW5056121. THERE IS NO INFORMATION AVAILABLE CONCERNING SERIAL NUMBER, HOSPITAL/CONTACT INFORMATION, OR EQUIPMENT CHECKOUT RESULTS. FURTHER INVESTIGATION INTO THE REPORTED COMPLAINT CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    GE HEALTHCARE IS IN RECEIPT OF A USER FILED MEDWATCH REPORT WHICH STATES, "ANESTHESIA MACHINE BELLOWS NOT WORKING. PATIENT REQUIRED MANUALLY BAGGING WITH O2 WHILE MACHINE WAS SWITCHED OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740553 AVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1