BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C625 MANUAL TRAVERSE OMNI

    MDR report key: 7140438 · Received December 21, 2017

    Report

    Report Number
    3007802293-2017-00019
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 29, 2017
    Report Date
    December 21, 2017
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    A TRAVERSING GANTRY FAIL ON (B)(6) 2017. HANDICARE TECH. SERVICE (B)(4) WENT ON-SITE DEC. 4, 2017 TO EVALUATE THE GANTRY SYSTEM IN USE SINCE SEPT. 2010. THE INSTALLATION CONSISTS OF A CEILING LIFT THAT MOVES ON A TRAVERSING GANTRY ATTACHMENT PLATE. THE GANTRY IS ATTACHED TO THE PLATE WITH 4 BOLTS, 2 ON EACH END WITH 4 BOLTS, 2 ON EACH END, TO A GANTRY ATTACHMENT PLATE IN A SANDWICH CONFIGURATION. THE ENTIRE ASSEMBLY IS HELD BY VERTICAL SUPPORTS MOUNTED TO WALLS WITH FASTENERS. THE GANTRY RAIL SHOWED NO ABNORMAL DAMAGE OR DEFORMATION OF THE ENDS. THE COATING IS WORN THROUGH THE BOTTOM OF THE GANTRY WHERE IT CONTACTS THE ATTACHMENT PLATE ON THE END THAT DETACHED, INDICATING LONG-TERM FRICTION/MOVEMENT BETWEEN THE GANTRY AND THE ATTACHMENT PLATE. THIS SUGGESTS THE BOLTS WEREN'T T ADEQUATELY TIGHT. THE BOLTS CONTINUED TO BE ATTACHED TO THE GANTRY ATTACHMENT PLATE AFTER THE GANTRY FELL. THE FALL OCCURRED ON THE END OF THE FIXED RAIL CLOSEST TO A VERTICAL SUPPORT. SOME LATERAL MOVEMENT OF THE VERTICAL SUPPORT WAS VISIBLE DURING (B)(4) 'S VISIT. THE ANALYSIS INDICATES THAT DOUBLE FAILURE MODES MUST OCCUR IN ORDER FOR THE GANTRY TO BECOME DETACHED: THE BOLTS IN THE TRAVERSING GANTRY MUST BE LOOSE. THE GANTRY MUST EITHER MOVE AWAY (HORIZONTALLY, NOT SIDE TO SIDE) FROM THE ATTACHMENT PLATE IT SITS ON OR THE FIXED RAIL AND ATTACHMENT PLATE MUST MOVE AWAY FROM THE GANTRY OR A COMBINATION OF BOTH. MAINTENANCE HAS BEEN PERFORMED ON THE INSTALLATION AS RECENT AS SEPTEMBER 2017. ROOT CAUSE: THE GANTRY FELL BECAUSE THERE WAS LATERAL MOVEMENT OF THE VERTICAL SUPPORT WHICH ALLOWED THE GANTRY TO MOVE OFF THE ATTACHMENT PLATE BECAUSE THE BOLTS WERE NOT ADEQUATELY TIGHT. CORRECTIVE ACTION: (B)(4) TEST CEILING TRACK SYSTEMS TO CONFIRM: · TOGGLE BOLTS THAT AFFIX THE WALLMOUNT POST TO THE WALL ARE INSTALLED AND TIGHTENED. · BOLTS ON BRACKET OF ABOVE MOUNT GANTRY ARE TIGHTENED TO MANUFACTURER RECOMMENDED TORQUE: 30.9 FT-LBS. · LOAD TEST ALL CEILING TRACK TO 125% LOAD CAPACITY OF CEILING LIFT. · PRE-DRILLED HOLES ALONG THE UPRIGHT SUPPORT HAVE A CORRECTLY INSTALLED TOGGLE BOLT FIXING THE SUPPORT TO THE WALL.

    Description of Event or Problem · 1

    A CLIENT WAS IN A SLING BEING LOWERED FROM SHOWERCHAIR TO BED AT THE (B)(6) IN (B)(6) AS THE CLIENT WAS LOWERED SAFELY TO THE BED THE TRAVERSING BOOM TRACK RAIL FELL TO THE FLOOR. THE CLIENT WAS NOT INJURED. A HEALTHCARE WORKER TRIED TO CATCH THE RAIL WHILE IT WAS FALLING TO KEEP THE CLIENT SAFE. THE HEALTHCARE WORKER SUSTAINED A FRACTURED BONE IN THE HAND/WRIST AREA AND HAD TO SEE AN ORTHOPEDIST FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919461 C625 MANUAL TRAVERSE OMNI C625 LIFT FSA HANDICARE USA INC. 323417

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S