BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1961208 · Received January 11, 2011

    Report

    Report Number
    9617766-2011-00056
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    January 31, 2008
    Report Date
    January 11, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED FAILURE COULD NOT BE DUPLICATED. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY FAILED TO X-RAY. 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 8800

    Patients

    Seq Age Sex Outcome Treatment
    1