BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2395127 · Received November 23, 2011

    Report

    Report Number
    9680959-2011-02229
    Event Type
    Malfunction
    Date Received
    November 23, 2011
    Date of Event
    October 21, 2011
    Report Date
    November 23, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE BSA BOARD AND THE NWA BOARD DURING THE SERVICE CALL. THE SYSTEM WAS FOUND TO BE WORKING AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1