BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2833270 · Received October 26, 2012

    Report

    Report Number
    1720753-2012-08726
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 26, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYSTEM WAS OPERATING AS INTENDED. HOWEVER, AS A PRECAUTIONARY MEASURE, THE SERVICE REP ADJUSTED THE PS2 POWER SUPPLY VOLTAGE AND RESEATED THE GIB AND FFB BOARDS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A WHITE SCREEN AND WOULD NOT DISPLAY A USABLE FLUOROSCOPIC LIVE IMAGE. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1