BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 2934184 · Received January 3, 2013

    Report

    Report Number
    1720753-2013-00125
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE RIGHT DISPLAY WAS BLACK AND THE SYSTEM LOCKED UP DURING SUBTRACTION WITH A GEN STACK OVERFLOW SOFTWARE COMM ERROR. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4158 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9600

    Patients

    Seq Age Sex Outcome Treatment
    1