BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOLIFT SMART

    MDR report key: 3129780 · Received May 21, 2013

    Report

    Report Number
    3004137175-2013-00003
    Event Type
    Death
    Date Received
    May 21, 2013
    Date of Event
    January 11, 2009
    Report Date
    May 21, 2013
    Manufacturer
    ETAC AS (DIVISION ETAC SUPPLY GJOVIK, NORWAY)
    Product Code
    FSA
    Removal / Correction Number
    3004137175-2/15/13-002-C
    Adverse Event
    Yes
    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 PT HOIST WERE RECEIVED BY MOLIFT BETWEEN 2007 AND 2009. MOLIFT GROUP AS PREVIOUSLY REPORTED ONE INCIDENT ON FORM 3500A (FORM 3500A, MFR REPORT # (B)(4), DATED 03/18/2008). UPON INVESTIGATION, IN 2009, PRIOR TO THE ACQUISITION OF 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 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 NO. 3004137175-2/15/13-002-C). CONCLUSION ON BEHALF OF MOLIFT: IT WOULD BE OUR UNDERSTANDING THAT THE COLUMN HAS BEEN PLACED IN THE BASE WHILE LEGS WERE CLOSED, THEN LOCKDOWN HANDLE WOULD HAVE BEEN ENGAGED, THEN LEGS OPENED. THIS WOULD HAVE RESULTED IN THAT, THE COLUMN WOULD HAVE STAYED UPRIGHT UNTIL WEIGHT WAS APPLIED. THIS IN TURN WOULD THEN PULL COLUMN FORWARD, AS A RESULT, THE COLUMN WOULD THEN COLLAPSE AS THE FORCE WOULD PULL FORWARD AND DISENGAGE LOCK HANDLE, ALLOWING COLUMN AND BOOM TO MOVE FORWARD.

    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 ALLEGED TO DROP INTO THE BASE COMPLETELY, THE LOCKING HANDLE CANNOT BE PULLED DOWN. THE MAST-BOOM OF A HOIST SUPPLIED TO (B)(6) COLLAPSED DURING PT TRANSFER, RESULTING IN THE PT'S BEING DROPPED ONTO THE FLOOR. THE HOIST WAS TRANSFERRED BY MOBILE CARE STAFF TO THE PT'S HOME, ASSEMBLED IN THE KITCHEN, AND MOVED INTO A BEDROOM TO TRANSFER THE PT FROM A BED TO AN ARMCHAIR. WHILE THE PT WAS SUSPENDED, THE HOIST WAS MOVED AWAY FROM THE BED AND STRUCK AN OBJECT ON THE FLOOR, WHEREUPON THE MAST DROPPED TO THE FLOOR AND THE USER FELL TO THE FLOOR. THE USER SUSTAINED INJURIES FROM THE FALL AND DIED 3 DAYS LATER IN HOSPITAL. THIS INCIDENT WAS REPORTED TO THE MFR, MOLIFTY, PRIOR TO ITS ACQUISITION BY ETAC. UPON INVESTIGATION AND INSPECTION OF THE HOIST IN THE (B)(6), MOLIFT CONCLUDED THAT OPERATOR FAILURE TO COMPLETELY FIT THE MAST INTO THE BASE HAD CAUSED THE MAST TO BECOME UNSTABLE. THIS CONCLUSION WAS CONSISTENT WITH THAT OF THE (B)(6) AND AN INJURY INQUEST VERDICT THAT THE DEATH WAS CAUSED BY USE OF THE HOIST WHILE IT WAS INCORRECTLY ASSEMBLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225173 MOLIFT SMART LIFT, PATIENT, NON-AC-POWERED - FSA FSA ETAC AS (DIVISION ETAC SUPPLY GJOVIK, NORWAY) MOLIFT SMART

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death