BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 2600

    MDR report key: 1040841 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21368
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 8, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE AUXILIARY INTERFACE BOARD WAS REPLACED AND THE KV TRACKING WAS CALIBRATED DURING THE SERVICE CALL. THERE WERE SPIKES IN POWER FOUND FROM THE OUTLET. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2600 SYSTEM HAD POOR IMAGE QUALITY. THE IMAGE WAS JUMPY AND UNCLEAR. 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