Description of Event or Problem · 1
ACORN MOBILITY SERVICES LTD ("ACORD (B)(4)") THE MANUFACTURING CORP. OF THE MEDICAL DEVICE CONCERNED, WAS, IN LATE (B)(4) 2013, CONTACTED BY THE (B)(6) CORONER'S OFFICES TO PROVIDE ASSISTANCE FOR THEIR INVESTIGATIONS INTO A FATAL ACCIDENT IN THE (B)(6) INVOLVING THE ACORN 120 STRAIGHT STAIRLIFT. ACORN (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 FO 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 STAIRLIFTS 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 ADDITIONAL INCIDENT (SEE MEDWATCH SUBMISSION FOR PATIENT IDENTIFIER (B)(6)), ACORN (B)(4) HAS, AS A PRECAUTIONARY MEASURE, DECIDED TO IMPLEMENT A SEATPOST REPLACEMENT PROGRAMME ON A WORLDWIDE BASIS. THIS IS DESPITE THERE BEING NO OFFICIAL OR CONFIRMED LINK ON THE CAUSES OF FAILURE FOR THE TWO INCIDENTS, THE LIMITED INFORMATION ACORN UK 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 THE (B)(6). THE TYPE OF SEATPOSTS POTENTIALLY IMPLICATED IN THESE INCIDENTS WERE USED IN APPROXIMATELY (B)(4) STAIRLIFTS, MANUFACTURED BETWEEN THE DATES OF (B)(4) AND DISTRIBUTED WORLDWIDE. THE STAIRLIFTS CAN BE IDENTIFIED BY UNIQUE SERIAL NUMBERS (B)(4).