BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6500 ELITE

    MDR report key: 6053619 · Received October 25, 2016

    Report

    Report Number
    6053619
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    April 29, 2016
    Report Date
    September 30, 2016
    Manufacturer
    SKYTRON, LLC
    Product Code
    JEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO BUTTONS ON THE OPERATING ROOM TABLE DIDN'T WORK FOR REFLEX POSITIONING FOR KNEE CASE. OPTIMAL POSITION NOT REACHED. THIS IS AN OLD DEVICE NO LONGER SUPPORTED BY MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705544 6500 ELITE TABLE, SURGICAL JEB SKYTRON, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR