BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMINGO

    MDR report key: 6158600 · Received December 9, 2016

    Report

    Report Number
    2112667-2016-02400
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    November 14, 2016
    Report Date
    December 9, 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

    A GEHC SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. THE COMPACT FLASH CARD WAS REPLACED. 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 BUT IS A SIMILAR DEVICE TO THE AVANCE 510(K) K032803.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT HAD A RESET ERROR. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809085 AMINGO ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1