BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2043015 · Received March 25, 2011

    Report

    Report Number
    9617766-2011-00718
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    December 22, 2010
    Report Date
    March 25, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE X-RAY TUBE WAS REPLACED AS A PREVENTATIVE MEASURE OR IF THE SYSTEM EXHIBITED AN ACTUAL FAILURE. NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE X-RAY TUBE NEEDED TO BE REPLACED. NO PATIENT 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 (GE PRIVATE) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1