BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 3162029 · Received June 3, 2013

    Report

    Report Number
    1720753-2013-06694
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE HIGH VOLTAGE CABLE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED A COMMUNICATION ERROR. THIS ERROR WILL CAUSE THE SYSTEM TO LOCKUP, SHUT DOWN, OR NOT TO BOOT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243820 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 2800

    Patients

    Seq Age Sex Outcome Treatment
    1