BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMINGO

    MDR report key: 6223019 · Received January 4, 2017

    Report

    Report Number
    2112667-2017-00021
    Event Type
    Malfunction
    Date Received
    January 4, 2017
    Date of Event
    December 4, 2016
    Report Date
    February 6, 2017
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS EVALUATED BY THE GEHC SERVICE DEPOT THE ERROR LOGS WERE REVIEWED AND INDICATED THAT THE CONNECTION BETWEEN THE POWER MANAGEMENT BOARD AND THE DISPLAY UNIT WAS LOST. GEHC WILL REPLACE THE CENTRAL PROCESSING UNIT.

    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. PATIENT INFORMATION COULD NOT BE OBTAINED DUE TO COUNTRY PRIVACY LAWS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. THE UNIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO AVANCE 510(K) K032803. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A CASE, THE UNIT SHUT OFF. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5670 AMINGO ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1