BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1852081 · Received September 28, 2010

    Report

    Report Number
    1720753-2010-03258
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 11, 2010
    Report Date
    September 28, 2010
    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 REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED NOR DUPLICATED. HOWEVER, THE UNIVERSAL SERIAL BUS CABLE ON THE SINGLE BOARD COMPUTER WAS RESEATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A BLANK IMAGE AND WOULD NOT REBOOT. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1