BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 4030033 · Received July 30, 2014

    Report

    Report Number
    1720753-2014-06444
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 29, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE IFB BOARD WAS EVALUATED AND REPLACED. THE SYSTEM BOARDS AND CONNECTORS WAS RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN IFB TIMEOUT. THE SYSTEM WILL NOT OPERATE WITH THIS ERROR. THIS RESULTED A TOTAL LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORTS OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446222 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1