BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 3190040 · Received June 18, 2013

    Report

    Report Number
    1720753-2013-07363
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS FOUND TO BE FAULTY DURING THE SERVICE CALL. THE PART IS NO LONGER AVAILABLE AND CANNOT BE ORDERED. THE CUSTOMER WILL SEEK REPAIR FROM THIRD PARTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM COULD NOT POWER UP AND THAT IT WAS THE BAD POWER SUPPLY THAT WAS PREVENTING THE MONITORS FROM WORKING. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276536 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1