BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2971177 · Received February 1, 2013

    Report

    Report Number
    9680959-2013-00287
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 1, 2013
    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 CONNECTORS WERE RESEATED, THE POWER SUPPLY WAS REPLACED, AND THE SOFTWARE UPGRADE WAS INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY SYSTEM WOULD NOT BOOT UP. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45516 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1