BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSYSTEM

    MDR report key: 8695416 · Received June 13, 2019

    Report

    Report Number
    8695416
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 17, 2019
    Manufacturer
    TRUMPF MEDICAL SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CLEAN ABILITY AND DISINFECTION ISSUES WITH THIS OPERATING TABLE. MANY NOOKS AND CREVICES TO RETAIN OVERFLOW IRRIGATION/BODILY FLUIDS. DETAILED INSTRUCTIONS AND DRAWINGS/DIAGRAMS FOR REMOVING TABLE PARTS FOR THOROUGH CLEANING ARE NOT INCLUDED IN MANUFACTURER'S INSTRUCTIONS FOR USE AND CARE, CLEANING AND DISINFECTION. THIS LEADS TO AN ISSUE WHERE THESE FLUIDS CAN DRY AND CREATE ENVIRONMENTAL CLEANLINESS AND INFECTION CONTROL PROBLEMS. WORK AROUND SOLUTION FOR OVERFLOW OF FLUIDS DURING THE SURGICAL PROCEDURE PROVIDED BY SALES REP TO PREVENT IRRIGATION/BODILY FLUIDS FROM POOLING AND DRYING...PRIOR TO PATIENT TRANSFER TO TABLE, A PLASTIC BAG IS PLACED TO COVER OPENING ARE WHERE THE SEAT END OF THE OPERATING TABLE AND THE FOOT END OF THE OPERATING TABLE TOP MEET TO COLLECT DRAINING FLUIDS. AFTER EACH PROCEDURE, UNLESS THESE PARTS ARE REMOVED AND/OR DISASSEMBLED AND CHECKED/CLEANED, IT'S DIFFICULT TO SEE IF FLUIDS HAVE OVERFLOWED AND DRIED. MULTIPLE CLEANING PRODUCTS REQUIRED FOR CLEANING AND DISINFECTION AND SHOULD ONLY BE USED FOR THE RESPECTIVE PLASTIC VS STAINLESS STEEL PARTS OF TABLE. THIS MAKES CLEANING THE TABLE COMPLICATED AND SETS ONE UP FOR FAILURE. SEE INSTRUCTION MANUAL FOR CLEANING, PG 87-88.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489468 TRUSYSTEM TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA TRUMPF MEDICAL SYSTEMS, INC. 7000DV

    Patients

    Seq Age Sex Outcome Treatment
    1