BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACORN 120 STRAIGH STAIRLIFT

    MDR report key: 3901686 · Received April 2, 2014

    Report

    Report Number
    3003124453-2014-00002
    Event Type
    Death
    Date Received
    April 2, 2014
    Date of Event
    September 25, 2013
    Report Date
    April 1, 2014
    Manufacturer
    ACORN MOBILITY SERVICES LTD
    Product Code
    PCD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ACORN MOBILITY SERVICES LTD ((B)(4)) THE MFG CORPORATION OF THE MEDICAL DEVICE CONCERNED, WAS, IN (B)(4) 2013, CONTACTED BY (B)(6) TO PROVIDE ASSISTANCE FOR THEIR INVESTIGATIONS INTO A FATAL ACCIDENT IN (B)(6) INVOLVING THE ACORN 120 STRAIGHT STAIRLIFT. (B)(4) WERE INFORMED THAT THE INDIVIDUAL USING THE DEVICE HAD A HISTORY OF HEALTH PROBLEMS. FOLLOWING THIS CORRESPONDENCE, TWO MECHANICAL EXPERTS CONDUCTED AN INSPECTION OF THE STAIRLIFT ON (B)(4) 2013. THE EXPERTS OBSERVED THAT THE HORIZONTAL WELD SECURING THE SEATPOST BASE TO THE MAIN SEAT SUPPORT ASSEMBLY OF THE STAIRLIFT USED BY THIS INDIVIDUAL HAD FAILED. AFTER THIS INCIDENT, ACORN (B)(4) CONDUCTED INDEPENDENT TESTS OF SEATPOSTS FROM SIMILAR STAIRLIFT AND THE TEST RESULTS HAVE REVEALED NO ISSUES REGARDING POTENTIAL FAILURES OF SEATPOSTS. NEVERTHELESS, AS A RESULT OF THIS EVENT AND THE EXISTENCE OF ONE ADD'L INCIDENT ((B)(6)), ACORN (B)(4) HAS, AS A PRECAUTIONARY MEASURE, DECIDED TO IMPLEMENT A SEATPOST REPLACEMENT PROGRAM ON A (B)(4) BASIS. THIS IS DESPITE THERE BEING NO OFFICIAL OR CONFIRMED LINK ON THE CAUSES OF FAILURE FOR THE TWO INCIDENTS, THE LIMITED INFO ACORN (B)(4) HAS REGARDING THE INCIDENTS AND THE POSITIVE TEST RESULTS RELATED TO THE STRUCTURAL INTEGRITY OF SIMILAR STAIRLIFT PRODUCTS. ACORN (B)(4) IS NOT AWARE OF ANY INCIDENTS INVOLVING FAILURE OF THE HORIZONTAL WELD SECURING THE SEATPOST BASE TO THE MAIN SEAT SUPPORT ASSEMBLY OF THE STAIRLIFT ANYWHERE OTHER THAN (B)(6). THE TYPE OF SEATPOSTS POTENTIALLY IMPLICATED IN THESE INCIDENTS WERE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199951 ACORN 120 STRAIGH STAIRLIFT POWERED STAIRWAY CHAIR LIFT PCD ACORN MOBILITY SERVICES LTD ACORN 120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death