BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-ARM

    MDR report key: 1781105 · Received July 29, 2010

    Report

    Report Number
    1720753-2010-02203
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    May 11, 2010
    Report Date
    July 29, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE IGBT MODULE WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM LOST ITS CALIBRATION AND AMPERAGE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-ARM FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1