BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2043533 · Received March 28, 2011

    Report

    Report Number
    9617766-2011-00742
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    August 20, 2010
    Report Date
    March 28, 2010
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE FLASH MEMORY WAS RELOADED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 8800 SYSTEM DISPLAYED A COMMUNICATION FAILURE ERROR MESSAGE. NO PT 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