BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOLIFT MOVER 180

    MDR report key: 3808192 · Received December 12, 2013

    Report

    Report Number
    3004137175-2013-00009
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Date of Event
    November 21, 2013
    Report Date
    December 11, 2013
    Manufacturer
    ETAC AS (DIVISION ETAC SUPPLY GJOEVIK, NORWAY
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE ACTUAL AFFECTED SUSPENSION NOT PERFORMED BY THE MANUFACTURER. REPORTS FROM DISTRIBUTOR INDICATES THAT ALL 4 SET SCREWS SECURING COMPOSITE HOOK TO SUSPENSION IS MISSING. REVIEW OF THE MANUFACTURERS ASSEMBLY INSTRUCTION VERIFY THAT INSTALLATION OF SET SCREWS AFTER APPLYING THREAD LOCKER IS SPECIFIED AND ILLUSTRATED. THUS THE ASSEMBLY INSTRUCTIONS IS CORRECT AND UP TO DATE. REVIEW OF TRAINING HISTORY CONFIRMS THAT THE OPERATOR WAS TRAINED IN THE ASSEMBLY OF THIS DEVICE. INITIAL PREVENTATIVE ACTIONS INCLUDE ENHANCEMENT OF THE ROUTINES FOR FINAL TESTING. VISUAL INSPECTION IS NOW TO BE PERFORMED BY TWO OPERATORS. INITIAL CORRECTIVE ACTION INCLUDES INSPECTION AND VERIFICATION OF ALL SUSPENSIONS IN MANUFACTURER'S STOCK BEFORE SHIPPING TO CUSTOMERS.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651407 MOLIFT MOVER 180 LIFT, PATIENT, NON-AC-POWERED FSA ETAC AS (DIVISION ETAC SUPPLY GJOEVIK, NORWAY

    Patients

    Seq Age Sex Outcome Treatment
    1