BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2100451 · Received May 13, 2011

    Report

    Report Number
    9617766-2011-01051
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 13, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE MONOBLOCK WAS REPLACED, THE FILAMENT WAS CALIBRATED, AND THE COLLIMATOR WAS ALIGNED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A FILAMENT REGULATOR FAILURE ERROR MESSAGE DURING FLUOROSCOPY, AND WOULD NOT DISPLAY AN IMAGE. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1