BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2994174 · Received February 13, 2013

    Report

    Report Number
    1720753-2013-01745
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 13, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. A FILAMENT CALIBRATION WAS PERFORMED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A "HIGH MA" ERROR MESSAGE AND THE SYSTEM WAS DOWN. THE X-RAY FUNCTION WAS DISABLED AND THIS OCCURRED OUTSIDE OF A PT PROCEDURE. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63886 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1