BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2152959 · Received June 17, 2011

    Report

    Report Number
    9617766-2011-01261
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 17, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. TECHNICAL SUPPORT WAS PROVIDED TO THE CUSTOMER, HOWEVER, AN ON SITE VISIT WILL BE REQUIRED. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM'S DISPLAYS WERE ILLUMINATED, HOWEVER, THE SETTINGS WOULD CHANGE INDEPENDENTLY AND THE C-ARM INTERMITTENTLY WOULD REBOOT. 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