BEUDAMED
    FDA Adverse Event Death Summary report: N

    AESPIRE 7900

    MDR report key: 7930283 · Received October 3, 2018

    Report

    Report Number
    2112667-2018-01933
    Event Type
    Death
    Date Received
    October 3, 2018
    Date of Event
    September 4, 2018
    Report Date
    October 3, 2018
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K050626
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. THE CENTRAL PROCESSING UNIT WAS REPLACED, AND THE UNIT WAS RETURNED TO SERVICE. NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. THE CENTRAL PROCESSING UNIT WAS REPLACED, AND THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT ALARMED DURING PREUSE CHECKOUT THAT REQUIRED A SYSTEM REBOOT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772326 AESPIRE 7900 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1