BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 2600

    MDR report key: 1253088 · Received December 9, 2008

    Report

    Report Number
    1720753-2008-20029
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. A F/U REPORT WILL BE FILED WHEN ADD'L DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2600 SYSTEM HAD A CHARGER FAILURE ERROR AT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1