BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1973618 · Received January 19, 2011

    Report

    Report Number
    1720753-2011-00385
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 19, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE X-RAY CONTROL BATTERY AND THE SOFTWARE WERE INSTALLED DURING THE SVC CALL. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN ROTATING THE IMAGE ON THE 9800 SYS THE IMAGE WILL ROTATE BACK ON ITS OWN DURING A CASE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1