BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 7900

    MDR report key: 6021235 · Received October 12, 2016

    Report

    Report Number
    2112667-2016-01993
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 16, 2016
    Report Date
    October 12, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K023366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER TROUBLESHOT THE FAILURE WITH GE HEALTHCARE TECHNICAL SUPPORT, THE PROPORTIONING THREADS WERE CLEANED AND THE SYSTEM WAS RECALIBRATED. THE UNIT WAS RETURNED TO SERVICE. NO REPORT OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A PROPORTIONING SYSTEM FAILURE, THE UNIT WAS ABLE TO DELIVER A HYPOXIC MIX. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674782 AESTIVA 7900 ANETHESIA MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1