BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2994177 · Received February 13, 2013

    Report

    Report Number
    1720753-2013-01743
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 13, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYSTEM WAS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SCREEN WENT BLACK AND A SYSTEM REBOOT WAS REQUIRED TO REGAIN FUNCTIONALITY. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63711 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1