BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 7900

    MDR report key: 5993809 · Received October 3, 2016

    Report

    Report Number
    2112667-2016-01929
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 7, 2016
    Report Date
    October 3, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K023366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER TROUBLESHOT THE REPORTED COMPLAINT WITH GE HEALTHCARE TECHNICAL SUPPORT. THE FLOW SENSORS WERE RECOMMENDED FOR REPLACEMENT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT ALARMED AND LOST THE ABILITY TO MANUALLY VENTILATE DURING A CASE. THE UNIT WAS SWITCHED TO MANUAL VENTILATION. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645338 AESTIVA 7900 ANETHESIA MACHINE CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR