BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPERATING TABLE COLUMN JUPITER SM 360 U

    MDR report key: 8647393 · Received May 28, 2019

    Report

    Report Number
    3007143268-2019-00005
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 29, 2019
    Report Date
    April 29, 2019
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. KG
    Product Code
    JEA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A TRUMPF MEDICAL SERVICE TECHNICIAN INSPECTED THE DEVICE AND FOUND THE SHUTTLE AND COLUMN INTERFACE TO BE OPERATING TO SPECIFICATION. INTERVIEWS WITH THE HOSPITAL STAFF REVEALED THAT THE TABLE TOP WAS PLACED ON THE SHUTTLE AND POSITIONED OVER THE JUPITER COLUMN, BUT NOT PUSHED ALL THE WAY AGAINST THE COLUMN AS REQUIRED BY THE INSTRUCTIONS FOR USE FOR THE JUPITER OPERATING TABLE COLUMN (INSTRUCTION MANUAL - 1 339 171). THE STAFF THEN RAISED THE COLUMN USING THE COLUMN KEYPAD RATHER THAN INITIATING THE TRANSFER VIA THE SHUTTLE PEDAL OR REMOTE CONTROL, AS REQUIRED BY THE INSTRUCTIONS FOR USE FOR THE JUPITER OPERATING TABLE COLUMN (INSTRUCTION MANUAL - 1 339 171). AN ENGINEERING ANALYSIS OF THE DATA LOGS RETRIEVED FROM OPERATING TABLE COLUMN JUPITER SM 360 U, MATERIAL# 1389824, SN (B)(4) CONFIRMED THAT ON (B)(6) 2019 THE CLEANING FUNCTION WAS INITIATED ON THE DAY OF THE EVENT. THE CLEANING FUNCTION CAN BE INITIATED WHEN THE COLUMN DOES NOT SENSE A TABLE TOP OR TRANSFER SHUTTLE AND A USER PUSHES THE ON BUTTON + THE RAISE BUTTON SIMULTANEOUSLY ON THE COLUMN KEY PAD. AFTER RELEASING THE BUTTONS, THE COLUMN WILL GO IN THE HIGHEST POSITION BY ITSELF AS A FEATURE TO FACILITATE CLEANING. THIS PROCEDURE IS DESCRIBED WITHIN THE JUPITER OPERATING TABLE COLUMN (INSTRUCTION MANUAL - 1 339 171) . THE TECHNICIAN CONFIRMED BY DEMONSTRATION THAT WHEN THE SHUTTLE AND TABLE TOP WERE FULLY ENGAGED WITH THE COLUMN THE SYSTEM WOULD NOT INITIATE THE CLEANING FUNCTION VIA THE COLUMN KEY PAD. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    DURING A TRANSFER OF A TABLE TOP ONTO THE COLUMN, THE TABLE TOP WAS SNAPPED OFF THE TRANSFER SHUTTLE CAUSING THE PATIENT TO SLIDE DOWN THE TABLE TOP UNTIL THEIR FEET LANDED ONTO THE FLOOR. TUBES BETWEEN THE PATIENT'S LEGS MOVED, RESULTING IN AN INTERNAL INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440033 OPERATING TABLE COLUMN JUPITER SM 360 U SURGICAL TABLE JEA TRUMPF MEDIZIN SYSTEME GMBH + CO. KG 1389824

    Patients

    Seq Age Sex Outcome Treatment
    1 Other