BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2982079 · Received February 8, 2013

    Report

    Report Number
    9680959-2013-00326
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    November 5, 2012
    Report Date
    February 8, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RELOADED SOFTWARE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM HAD SOFTWARE CORRUPTION WHICH CAUSED THE SYSTEM TO INTERMITTENTLY "HANG" OR LOCK UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55378 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1