BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2030485 · Received March 9, 2011

    Report

    Report Number
    1720753-2011-02050
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 9, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SERVICE REP REPLACED THE SOFTWARE. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 9600 SYSTEM SHUT DOWN, AND WOULD NOT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1