BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1941153 · Received December 22, 2010

    Report

    Report Number
    9617766-2010-00869
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 22, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVIATE LTD. (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CONTACTS OF THE DISPLAY BOARDS AND ADAPTER WERE EXAMINED. THE SYSTEM WAS FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED BLANK IMAGES. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1