BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 1860394 · Received September 27, 2010

    Report

    Report Number
    9680959-2010-00348
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 27, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. A CIRCUIT BOARD WAS REPLACED AND THE COLLIMATOR CALIBRATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED FATAL ERROR MESSAGES AND FAILED TO BOOT. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1