BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC 2800

    MDR report key: 1315790 · Received February 20, 2009

    Report

    Report Number
    1720753-2008-28305
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    November 3, 2008
    Report Date
    November 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE SURGE SUPPRESSOR WAS REPLACED DURING THE SVC CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MDR IS RELATED TO GE HEALTHCARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2800 SYSTEM NEEDED THE SURGE SUPPRESSOR REPLACED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1