BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOLIFT SMART

    MDR report key: 3130031 · Received May 22, 2013

    Report

    Report Number
    3004137175-2013-00001
    Event Type
    Other
    Date Received
    May 22, 2013
    Date of Event
    November 22, 2006
    Report Date
    May 21, 2013
    Manufacturer
    ETAC AS (DIV ETAC SUPPLY GJOEVIK, NORWAY)
    Product Code
    FSA
    Removal / Correction Number
    3004137175-2/15/13-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF FIVE REPORTS THAT MOLIFT CONCLUDED WERE THE RESULT OF USER FAILURE TO INSERT THE MAST FULLY INTO THE BASE OF THE MOLIFT SMART PATIENT HOIST WERE RECEIVED BY MOLIFT BETWEEN 2007 AND 2009. MOLIFT GROUP HAS PREVIOUSLY REPORTED ONE INCIDENT ON FORM 3500A (FORM 3500A, MFR REPORT NUMBER (B)(4), DATED 03/18/2008). UPON INVESTIGATION IN 2009, PRIOR TO THE ACQUISITION OF THE MOLIFT BY ETAC, MOLIFT UNDERTOOK A VOLUNTARY FIELD CORRECTION WITH THE OBJECTIVE OF REDUCING THE RISK OF INJURY RESULTING FROM OPERATOR FAILURE TO SPREAD THE LEGS FULLY INTO THE OPERATOR FAILURE TO SPREAD THE LEGS FULLY INTO THE OPERATOR POSITION AND FAILURE TO INSERT THE MAST FULLY INTO THE BASE. A FIELD SAFETY NOTICE (MOLIFT FSN 01-09) WAS ISSUED TO KNOWN OWNERS OF THE MOLIFT SMART IN THE U.S. AND OTHER JURISDICTIONS, ALONG WITH A GUIDANCE LABEL TO BE AFFIXED TO THE HOIST MAST AND AN UPDATED OPERATOR'S MANUAL. ETAC HAS RETROSPECTIVELY REPORTED THE CORRECTION BY MOLIFT TO FDA (REPORT NUMBER: 3004137175-2/15/13-002-C).

    Description of Event or Problem · 1

    THE MOLIFT SMART HOIST WAS DESIGNED SUCH THAT THE LEGS MUST BE SPREAD FULLY BEFORE THE MAST CAN BE FULLY INSERTED INTO THE BASE AND THE LOCKING HANDLE PULLED DOWN TO ENSURE STABILITY OF THE HOIST. IF THE MAST IS NOT ALLOWED TO DROP INTO THE BASE COMPLETELY, THE LOCKING HANDLE CANNOT BE PULLED DOWN. WHILE MEDICAL STAFF MEMBERS WERE USING THE HOIST TO MOVE A PATIENT, THE LIFTING COLUMN APPARENTLY MOVED WITHIN THE FIXING BRACKET, CAUSING THE LIFTING ARM OF THE HOIST TO MOVE FORWARD AND DOWNWARD TO THE FLOOR. THE PATIENT WAS NOT INJURED. THE INCIDENT REPORTEDLY RESULTED FROM THE USER'S FAILURE TO SECURE THE LOCKING HANDLE. THIS INCIDENT WAS REPORTED TO THE MFR, MOLIFT, PRIOR TO ITS ACQUISITION BY ETAC. UPON INVESTIGATION, MOLIFT CONCLUDED THAT OPERATOR FAILURE TO COMPLETELY FIT THE MAST INTO THE BASE HAD CAUSED THE MAST TO BECOME UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226680 MOLIFT SMART LIFT, PATIENT, NON-AC-POWERED -FSA FSA ETAC AS (DIV ETAC SUPPLY GJOEVIK, NORWAY) MOLIFT SMART

    Patients

    Seq Age Sex Outcome Treatment
    1