BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3943662 · Received April 30, 2014

    Report

    Report Number
    1720753-2014-03801
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 30, 2014
    Manufacturer
    GE OEC MEDICAL SYSETMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE MAIN BATTERIES WAS EVALUATED AND REPLACED. A COMPLETE FILAMENT CALIBRATION WAS PERFORMED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A PRECHARGE VOLTAGE ERROR. THIS ERROR WILL LIKELY PREVENT THE SYSTEM FROM BOOTING, WHICH WOULD RESULT IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258466 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSETMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1