BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 2600

    MDR report key: 1001262 · Received February 22, 2008

    Report

    Report Number
    1720753-2008-16366
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 22, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE WORKSTATION POWER SUPPLY AND THE IMAGE PROCESSOR WERE REPLACED DURING THE SVC CALL. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2600 SYS WOULD NOT BOOT UP PRIOR TO A CASE. 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