BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2891410 · Received December 6, 2012

    Report

    Report Number
    1720753-2012-10193
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 6, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SBC INTERCONNECT CABLE AND SYSTEM INTERFACE BOARD WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A 'FATAL SYSTEM ERROR DETECTED' ERROR MESSAGE AND THEY WERE UNABLE TO GET THE SYSTEM TO BOOT UP ALL THE WAY. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1