BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2093145 · Received May 3, 2011

    Report

    Report Number
    9680959-2011-01169
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 3, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE POWER CIRCUIT WAS REPAIRED AND THE TUBE WAS ADJUSTED. THE TRANSFORMER GRID INSIDE THE MACHINE WAS RESET. 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 THE SYSTEM PRODUCED AN ALARM EVEN WHILE IT WAS IN STANDBY MODE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1