BEUDAMED
    FDA Adverse Event Death Summary report: N

    AESPIRE VIEW

    MDR report key: 3692026 · Received March 13, 2014

    Report

    Report Number
    2112667-2014-00042
    Event Type
    Death
    Date Received
    March 13, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 17, 2014
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K092864
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CLINICIAN IMPROPERLY CONNECTED THE PATIENT CIRCUIT. PATIENT SUBSEQUENTLY DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150346 AESPIRE VIEW ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death