BEUDAMED
    FDA Adverse Event Death Summary report: N

    AESTIVA 7900

    MDR report key: 4903480 · Received July 9, 2015

    Report

    Report Number
    2112667-2015-00016
    Event Type
    Death
    Date Received
    July 9, 2015
    Date of Event
    June 10, 2015
    Report Date
    June 18, 2015
    Manufacturer
    DATEX-OHMEDA, INC
    Product Code
    BSZ
    PMA / PMN Number
    K023366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED TO GE HEALTHCARE THAT THE ROOT CAUSE OF THE FIRE WAS TRACED TO A NON-GE PIECE OF EQUIPMENT. A GEHC SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE GE EQUIPMENT AND FOUND IT TO FUNCTION WITHIN MANUFACTURER'S SPECIFICATIONS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A LASER ABLATION OF AN ENDOBRONCHIAL TUMOR (LUNG CANCER) CASE, A FIRE OCCURRED. THE PATIENT REPORTEDLY SUSTAINED BURNS TO THE BRONCHIAL/TRACHEA AREA. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND SUBSEQUENTLY DIED. THERE IS NO ALLEGATION THAT THE ANESTHESIA MACHINE MALFUNCTIONED. GE HEALTHCARE SERVICE REPRESENTATIVES PERFORMED A CHECKOUT OF THE ANESTHESIA MACHINE AND FOUND IT TO FUNCTION WITHIN MANUFACTURER'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445160 AESTIVA 7900 ANESTHESIA MACHINE BSZ DATEX-OHMEDA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death