BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 7900

    MDR report key: 6213338 · Received December 29, 2016

    Report

    Report Number
    2112667-2016-02549
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Date of Event
    December 29, 2016
    Report Date
    December 29, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K023366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE EQUIPMENT AND CONFIRMED THE REPORTED COMPLAINT. THE CENTRAL PROCESSING UNIT UPGRADE SWITCH WAS REPLACED, AND THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED RECEIVING A SYSTEM RESTART ALARM DURING PRE-USE CHECKOUT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864592 AESTIVA 7900 ANETHESIA MACHINE CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1