BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3192190 · Received June 20, 2013

    Report

    Report Number
    1720753-2013-07417
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 20, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RELOADED SYSTEM SOFTWARE AND CALIBRATION FILES. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED ERROR MESSAGES AND WOULD NOT COMPLETE BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280256 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1