BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2092194 · Received April 27, 2011

    Report

    Report Number
    1720753-2011-06626
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 27, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE WAS CALIBRATED AND THE KILOVOLT OUTPUTS WERE CHECKED. THE C-ARM DRIVE ASSEMBLY NEEDS TO BE REPLACED. NO ADD'L SERVICE INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 9600 SYSTEM NEEDS TO BE CALIBRATED AND THAT THE C-ARM WAS NOT ROTATING PROPERLY. 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