BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOLIFT MOVER 180

    MDR report key: 3808183 · Received December 6, 2013

    Report

    Report Number
    3004137175-2013-00008
    Event Type
    Malfunction
    Date Received
    December 6, 2013
    Date of Event
    November 6, 2013
    Report Date
    November 25, 2013
    Manufacturer
    ETAC AS (DIVISION ETAC SUPPLY GJOEVIK, NORWAY
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INSPECTION OF THE SUSPENSION REVEAL THAT ALL 4 SET SCREWS SECURING COMPOSITE HOOK TO SUSPENSION IS MISSING. SHOWS SIGNS OF THAT SET SCREWS NEVER HAS BEEN MOUNTED. INSPECTION OF ASSEMBLY INSTRUCTION VERIFY THAT INSTALLATION OF SET SCREWS AFTER APPLYING THREAD LOCKER IS SPECIFIED AND ILLUSTRATED. THUS THE ASSEMBLY INSTRUCTIONS WERE UP TO DATE. REVIEW OF DHR SHOWS THAT THE OPERATOR WAS TRAINED IN THE ASSEMBLY OF THIS DEVICE. INITIAL PREVENTIVE ACTIONS INCLUDE UPDATE OF THE ROUTINES FOR FINAL TESTING. VISUAL INSPECTION IS NOW TO PERFORMED BY TWO OPERATORS. INITIAL CORRECTIVE ACTION INCLUDES INSPECTION AND VERIFICATION OF ALL SUSPENSIONS IN STOCK BEFORE SHIPPING TO CUSTOMERS.

    Description of Event or Problem · 1

    PATIENT HOIST USED FOR TRANSFERRING PATIENT. COMPOSITE HOOK ON SUSPENSION, SECURING THE SLING TO THE HOIST, DETACHES FROM THE SUSPENSION DURING FIRST TIME USE. RESULTING IN THE PATIENT FALLING OUT OF THE SLING AND ONTO THE FLOOR. NO PHYSICAL INJURY RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635000 MOLIFT MOVER 180 LIFT, PATIENT, NON-AC-POWERED FSA ETAC AS (DIVISION ETAC SUPPLY GJOEVIK, NORWAY

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other