BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3241079 · Received July 18, 2013

    Report

    Report Number
    1720753-2013-08326
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 18, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND PLUGGED THE SYSTEM IN TO CHARGE THE BATTERIES. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PRECHARGE VOLTAGE ERROR. THIS ERROR WILL PREVENT THE SYSTEM FROM BOOTING, RESULTING IN A LOSS OF IMAGING FUNCTIONALITY. THIS COULD RESULT IN THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335320 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1