BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2971355 · Received February 4, 2013

    Report

    Report Number
    1720753-2013-01433
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE X-RAY MONOBLOCK, HARD DRIVE, AND THE SBC UPGRADE KIT WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM SHUT DOWN WHEN IT BOOTS UP. THERE IS NO REPORT OF PT INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47349 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1