BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMINGO

    MDR report key: 6215801 · Received December 30, 2016

    Report

    Report Number
    2112667-2016-02570
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 30, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 AMINGO IS NOT SOLD IN THE USA AND HAS NO 510(K). HOWEVER, THE DEVICE IS SIMILAR TO THE AVANCE, 510(K) K032803. A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT AND FOUND THE EQUIPMENT TO FUNCTION WITHIN MANUFACTURER'S SPECIFICATIONS. THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE UNIT SHUT OFF WHEN THE PATIENT WAS MOVED TO THE OPERATING ROOM. THE UNIT WAS REBOOTED, RESOLVING THE REPORTED COMPLAINT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865789 AMINGO ANESTHESIA MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1