BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1941305 · Received December 16, 2010

    Report

    Report Number
    1720753-2010-04764
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    April 12, 2010
    Report Date
    December 16, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE BURNING SMELL COULD NOT BE DUPLICATED. THE LEG EXTENSION WAS CLEANED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 2800 SYSTEM LEG EXTENSION WAS STUCK AND THERE WAS A BURNING SMELL COMING FROM THE SYSTEM. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1