BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3843396 · Received March 14, 2014

    Report

    Report Number
    1720753-2014-02330
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 21, 2014
    Report Date
    March 14, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC0
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM SWITCHED OFF. THIS RESULTED IN A 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
    153374 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC0 9600

    Patients

    Seq Age Sex Outcome Treatment
    1