BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 4203067 · Received September 18, 2014

    Report

    Report Number
    1720753-2014-07998
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 18, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FSE RESEATED ALL POWER CONNECTIONS TO THE IMAGE INTENSIFIER POWER SUPPLY. WORKSTATION PCB ASSEMBLIES WERE RESEATED AND PROPER DC VOLTAGE WAS CONFIRMED DURING THE SERVICE EVENT. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SYSTEM VIDEO FROZE AND LOCKED UP. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578797 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1