BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOLIFT SMART

    MDR report key: 3130033 · Received May 22, 2013

    Report

    Report Number
    3004137175-2013-00004
    Event Type
    Other
    Date Received
    May 22, 2013
    Date of Event
    May 18, 2009
    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
    NOT APPLICABLE

    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 (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. IF THE MAST IS NOT ALLOWED TO DROP INTO THE BASE COMPLETELY, THE LOCKING HANDLE CANNOT BE PULLED DOWN. DURING A TRAINING DEMONSTRATION AT (B)(6) HOSPITAL, A STAFF MEMBER WAS PLACED IN THE HOIST AND LIFTED FROM A WHEELCHAIR TO BE TRANSPORTED TO A BED. WITH THE STAFF MEMBER SITTING IN THE SLING, THE HOIST COLLAPSED. THE STAFF MEMBER FELL TO THE FLOOR AND SUSTAINED BRUISING TO COCCYX BUT WAS NOT X-RAYED. A STAFF MEMBER WHO ASSEMBLED THE HOIST REPORTEDLY TOLD THE MHRA THAT SHE BELIEVED SHE HAD CORRECTLY ASSEMBLED THE HOIST; ANOTHER STAFF MEMBER REPORTEDLY TOLD THE MHRA THAT SHE WAS UNFAMILIAR WITH THE CORRECT ASSEMBLY PROCEDURE AND THIS WAS THE REASON FOR THE TRAINING. THIS INCIDENT WAS REPORTED TO THE MFR, MOLIFT, PRIOR TO ITS ACQUISITION BY ETAC. A RELABELING EFFORT TO REDUCE THE RISK OF INCORRECT ASSEMBLY WAS ALREADY UNDER WAY AT THE TIME OF THE REPORT. 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
    226945 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