BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1921625 · Received December 7, 2010

    Report

    Report Number
    9617766-2010-00817
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 17, 2010
    Report Date
    December 7, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE 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 FLUORO FUNCTIONS BOARD AND A FUSE WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP. NO REPORT OF PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1