BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA 7900

    MDR report key: 6119612 · Received November 21, 2016

    Report

    Report Number
    2112667-2016-02266
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 25, 2016
    Report Date
    November 21, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K023366
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED THAT THE ISSUE WAS RESOLVED BY THE CUSTOMER AFTER REPLACING THE FLOW SENSORS. SUBSEQUENTLY, THE GE HEALTHCARE SERVICE REPRESENTATIVE WAS CALLED TO THEIR SITE TO LOOK AT THE UNIT AND FIX THE LEAK. THE GE HEALTHCARE SERVICE REPRESENTATIVE REPLACED THE DRAIN VALVE TO RESOLVE THE ISSUE.

    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 BIOMEDICAL ENGINEER TROUBLESHOT THE REPORTED COMPLAINT WITH GE HEALTHCARE TECHNICAL SUPPORT.. THE FLOW SENSORS WERE REPLACED, AND THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE UNIT HAD A LARGE LEAK PREVENTING MECHANICAL VENTILATION. THE CASE WAS CONTINUED IN MANUAL VENTILATION MODE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770009 AESTIVA 7900 ANETHESIA MACHINE CBK DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1