BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOLIFT SMART

    MDR report key: 3130032 · Received May 22, 2013

    Report

    Report Number
    3004137175-2013-00002
    Event Type
    Other
    Date Received
    May 22, 2013
    Date of Event
    January 16, 2008
    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
    US
    Reporter Occupation
    OTHER

    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. (B)(4). 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 (B)(4) 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. THE PATIENT'S SON (REPORTER) REPORTED THE INCIDENT TO THE U.S. DISTRIBUTOR DURING A CALL TO ORDER A PART. A HEALTHCARE AID WHO HELPED HIS MOTHER WITH DAILY TRANSFER USING THE HOIST SET UP THE HOIST AND ATTEMPTED TO USE IT TO TRANSFER THE PATIENT FROM A WHEELCHAIR TO A BED. AS THE PATIENT WAS BEING LOWERED TO THE BED, THE HOIST'S LOCKING MECHANISM CAME APART AT THE JOINT. THE PATIENT WAS DROPPED ONTO THE BED AND REPORTEDLY HAD "RUG BURN" (SKIN ABRASIONS) FROM THE PADDING ON THE HOIST SUSPENSION. THE REPORTER CONFIRMED THAT THE AID HAD NOT BEEN TRAINED TO SET UP THE HOIST AND HAD NOT FOLLOWED THE ASSEMBLY INSTRUCTIONS PROVIDED WITH THE HOIST. THE REPORTER REPORTED THAT THE LOCKING MECHANISM HAD BROKEN AS A RESULT OF IMPROPER ASSEMBLY BY THE AID. THIS INCIDENT WAS REPORTED TO THE MFR, MOLIFT, PRIOR TO ITS ACQUITION BY ETAC. UPON INVESTIGATION, MOLIFT CONCLUDED THAT OPERATOR FAILURE TO COMPLETELY FIT THE MAST INTO THE BASE HAD CAUSED THE MAST TO BE UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227632 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