BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOLIFT MOVER 180

    MDR report key: 3772396 · Received March 11, 2014

    Report

    Report Number
    3004137175-2014-00001
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    February 12, 2014
    Report Date
    March 11, 2014
    Manufacturer
    ETAC AS (DIVISION ETAC SUPPLY GJOEVIK, NORWAY)
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION ACTUAL AFFECTED SUSPENSION HAS BEEN PERFORMED BY THE MFR. SUSPENSION IS RETURNED WITH ALL 4 SET SCREWS SECURING COMPOSITE HOOK TO SUSPENSION MISSING. REVIEW OF THE MANUFACTURERS ASSEMBLY INSTRUCTIONS VERIFY THAT INSTALLATION OF SET SCREWS IS SPECIFIED AND ILLUSTRATED. THUS ASSEMBLY INSTRUCTIONS WAS CORRECT AND UP TO DATE AT THE TIME OF ASSEMBLY. REVIEW OF TRAINING HISTORY CONFIRMS THAT THE OPERATOR WAS TRAINED IN THE ASSEMBLY OF THIS DEVICE. WHEN INSPECTING THE NUTS SET SCREWS ARE BOLTED TO, MORE PRECISELY THE NYLON THREAD LOCKING BUSHING, GROVES FROM THREADS ON SET SCREWS HAVING BEEN INSERTED ARE CLEARLY VISABLE. FURTHERMORE THERE ARE SCRATCHES IN THE ALUMINIUM PROFILE OF THE SUSPENSION IDENTICAL TO THOSE MADE BY SET SCREWS BEING/HAVING BEEN INSERTED. THIS LEADS US TO THE CONCLUSION THAT THE SET SCREWS SECURING THE COMPOSITE HOOKS TO THE SUSPENSION HAS BEEN PRESENT. AT ONE TIME THE SUSPENSION HAS BEN TAMPERED WITH AND IS OUTSIDE OF MANUFACTURERS SPECIFICATION.

    Description of Event or Problem · 1

    PT HOIST USED FOR SALES TRANSFER OF PT. COMPOSITE HOOK ON SUSPENSION (CARRY BAR ), SECURING THE SLING TO THE HOIST, DETACHES FROM THE SUSPENSION (CARRY BAR) DURING THE FIRST DAY OF USE. RESULTING IN THE CLIENT FALLING OUT OF THE SLING AND ONTO A BED. NO PHYSICAL INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146310 MOLIFT MOVER 180 LIFT, PATIENT, NON-AC/POWERED FSA ETAC AS (DIVISION ETAC SUPPLY GJOEVIK, NORWAY)

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR