BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1981459 · Received February 1, 2011

    Report

    Report Number
    9617766-2011-00207
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 1, 2011
    Manufacturer
    GE MED SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE X-RAY TUBE AND PERFORMED A FILAMENT CALIBRATION. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING FLUORO THE SYSTEM WOULD INTERMITTENTLY DISPLAY A BLACK SCREEN AND A GENERATOR ERROR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE MED SYSTEMS (INDIA) PRIVATE LTD 8800

    Patients

    Seq Age Sex Outcome Treatment
    1