BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 2800040 · Received October 17, 2012

    Report

    Report Number
    1720753-2012-08398
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 17, 2012
    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

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FOOT SWITCH AND HAND SWITCH WERE REPLACED DURING THE SERVICE CALL. THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM LOCKED UP DURING A CASE. THE SYSTEM HAD TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1