BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1980132 · Received January 24, 2011

    Report

    Report Number
    1720753-2011-00545
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND FOUND THE 5 VOLTS GOING TO THE FLUORO FUNCTION BOARD TO BE SLIGHTLY LOW. GE REP ADJUSTED THE POWER SUPPLY VOLTAGE TO 5.2 VOLTS. TESTED AND VERIFIED PROPER OPERATION OF THE SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A COMMUNICATION ERROR BETWEEN THE GENERATOR AND THE WORKSTATION. NO PT INJURY WAS REPORTED.

    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