BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2101608 · Received May 11, 2011

    Report

    Report Number
    1720753-2011-07190
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 11, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE HIGH VOLT VOLTAGE CABLE, THE INTERCONNECT CABLE AND THE GENERATOR INTERFACE BOARD WERE REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY AN IMAGE AND THAT FLUOROSCOPY WAS INTERMITTENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1