BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3791788 · Received January 6, 2014

    Report

    Report Number
    1720753-2014-00152
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 18, 2013
    Report Date
    January 6, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP EVALUATED THE SYS AND COULD NOT REPRODUCE THE REPORTED PROBLEM. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYS WAS NOT SAVING PT IMAGES (DATA LOSS). THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8619 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1