BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2941193 · Received January 18, 2013

    Report

    Report Number
    1720753-2013-00803
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 18, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DISPLAYED INTERLOCK FAILURE ERROR MESSAGE. IT IS LIKELY TO RESULT IN A SYSTEM LOCKUP, NO BOOT, OR SHUT DOWN SITUATION DEPENDING ON WHEN THE LOSS OF COMMUNICATION. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28476 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1