BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2884901 · Received December 4, 2012

    Report

    Report Number
    1720753-2012-10084
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 21, 2012
    Report Date
    December 4, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE BATTERY PACK WAS REPLACED AND THE COLLIMATOR POTENTIOMETER WAS ADJUSTED 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

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT BOOT UP AND SHOWED A FILAMENT ERROR. THERE WAS NO PT INJURY OR DEATH 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