BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOLIFT SMART 150

    MDR report key: 3130085 · Received May 21, 2013

    Report

    Report Number
    3004137175-2013-00005
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    December 25, 2010
    Report Date
    May 21, 2013
    Manufacturer
    ETAC AS (DIVISIION ETAC SUPPLY GJOEVIK, NORWAY)
    Product Code
    FSA
    Removal / Correction Number
    3004137175-2/15/13-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ETAC RECEIVED A TOTAL OF THREE REPORTS RELATED TO LOCKING CLAMPS OF THE LEG-SPREADING MECHANISM OF THE MOLIFT SMART 150 HOIST BETWEEN 2010 AND 2011. AS A RESULT OF FURTHER INVESTIGATION, ETAC IDENTIFIED A SINGLE BATCH OF LOCKING CLAMPS SUPPLIED BY A NEW, THIRD-PARTY SUPPLIER THAT WERE COMPOSED OF STEEL THAT WAS OF A HARDNESS GRADE BELOW ETAC'S HARDNESS SPECIFICATION FOR THE COMPONENT. BEGINNING IN 2011, ETAC UNDERTOOK A VOLUNTARY FIELD CORRECTION IN THE U.S. AND OTHER JURISDICTIONS TO REPLACE THE LOCKING CLAMPS OF ALL DELIVERED HOISTS THAT COULD HAVE INCLUDED THESE LOCKING CLAMPS. ETAC HAS REPORTED THE CORRECTION TO FDA (3004137175-2/15/13-001-C).

    Description of Event or Problem · 1

    THE MOLIFT SMART 150 IS A FOLDABLE MOBILE HOIST AND IS INTENDED FOR LIFTING AND TRANSFERRING PATIENTS. THE LEG-SPREADING MECHANISM OF THE HOIST FEATURES TWO LOCKING CLAMPS, LOCATED BEHIND A GRAY FOAM COVER ON EITHER SIDE OF THE CHASSIS. LOOSENING OF A LOCKING CLAMP OF THE LEG-SPREADING MECHANISM CAN RESULT IN ONE OF THE LEGS EXCEEDING THE NORMAL OPERATING AREA, LEADING TO DESTABILIZATION OF THE HOIST. ETAC RECEIVED A REPORT FROM FINLAND THAT AFTER BEING USED FOR ONE WEEK, A MOLIFT SMART 150 HOIST COLLAPSED AND THE PATIENT FELL AGAINST A DOORWAY. THE PATIENT REPORTEDLY HAD "HURT MOUTH AND TONGUE"; NO FURTHER INJURIES OR DETAILS OR THIS INJURY WERE REPORTED. INVESTIGATION REVEALED THAT A COMPONENT OF THE LEG-SPREADING MECHANISM OF THE HOIST, A LOCKING CLAMP, HAD BECOME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225697 MOLIFT SMART 150 LIFT, PATIENT, NON-AC-POWERED - FSA FSA ETAC AS (DIVISIION ETAC SUPPLY GJOEVIK, NORWAY) MOLIFT SMART 150

    Patients

    Seq Age Sex Outcome Treatment
    1