BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2251456 · Received September 9, 2011

    Report

    Report Number
    1720753-2011-21801
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 9, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SVC REP ERASED AND RESTORED THE NODES AND RESTORED THE DATA SYS FUNCTIONALITY. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS DATA IS CORRUPT. THE SYS DISPLAYED COLLIMATOR CALIBRATION AND FILAMENT CALIBRATION REQUIRED ERROR MESSAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1