BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 2934689 · Received January 4, 2013

    Report

    Report Number
    1720753-2013-00211
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO WAS NOT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD INTERMITTENTLY LOCK-UP AND REQUIRED REBOOTING. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5817 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 2800

    Patients

    Seq Age Sex Outcome Treatment
    1