BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3210059 · Received July 3, 2013

    Report

    Report Number
    1720753-2013-07861
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE IMAGE PROCESSOR BOARD WAS REPLACED. THE SYSTEM WAS FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CINE PLAYBACK WAS INTERMITTENTLY NOT FUNCTIONING, WHICH RESULTED IN A LOSS SUBTRACTION, ROAD-MAPPING, OR OTHER CRITICAL VASCULAR CINE FUNCTIONS. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304979 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1