BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    990

    MDR report key: 3882930 · Received April 4, 2014

    Report

    Report Number
    1720753-2014-02956
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 4, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING AN ERROR DURING PROCEDURES THAT REQUIRED THE SYSTEM BE SHUT DOWN AND RESTARTED. THIS RESULTED IN AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205221 990 FLUORORSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1