BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMINGO

    MDR report key: 6213490 · Received December 29, 2016

    Report

    Report Number
    2112667-2016-02548
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 29, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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. GE HEALTHCARE¿S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ALREADY REPORTED ON MDR 2112667-2016-02570. THIS REPORT IS A DUPLICATE AND SHOULD BE DISREGARDED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT THE UNIT SHUT DOWN DURING THE PREOPERATIVE CHECKOUT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863020 AMINGO ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1