BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 1002746 · Received February 26, 2008

    Report

    Report Number
    1720753-2008-16406
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 26, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. REPLACED THE SIGNAL CABLE ASSEMBLY, THE TABLE DISK AND THE DISK DRIVE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2600 SYSTEM HAS A PROBLEM WITH THE TABLE. IT WAS NOTED THAT TABLE OVERLOADED AND WILL NOT GO UP OR DOWN. IT WAS ALSO NOTED THAT A GRINDING SOUND WAS HEARD. THERE WAS NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1