BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1963557 · Received December 20, 2010

    Report

    Report Number
    9617766-2010-00865
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 20, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE ENGINEER RELOADED THE SOFTWARE, CONFIGURED THE SYSTEM, AND RESTORED THE SYSTEM CALIBRATION AND CONFIGURATION DATA. THE SYSTEM WAS THEN FOUND TO BE OPERATING AT INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO PRINT AND SAVE IMAGES. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1