BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2891452 · Received December 6, 2012

    Report

    Report Number
    1720753-2012-10194
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    October 23, 2012
    Report Date
    December 6, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE X-RAY TUBE, THE PRECHARGE CIRCUIT BOARD, AND THE BATTERIES WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS NOT WORKING. THE FIELD ENGINEER CONFIRMED THAT THE X-RAY TUBE WAS NOT FUNCTIONAL AND THE GENERATOR HAD FAILED. 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