Description of Event or Problem · 1
ACORN MOBILITY SERVICES LTD ("ACORN UN") THE MFG CORPORATION OF THE MEDICAL DEVICE CONCERNED, HAS INFORMED ACORN INC. THE IMPORTING CORPORATION OF THE FOLLOWING. ACORN MOBILITY SERVICES LTD ("ACORN (B)(4)") THE MFG CORPORATION OF THE MEDICAL DEVICE CONCERNED, WERE CONTACTED, IN (B)(4) 2013, BY THE (B)(4)'S CORONERS 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 ACCIDENT INVOLVED A MALE INDIVIDUALS IN THE (B)(6) TOGETHER WITH AN INDICATION THAT THE STAIRLIFT WAS IN SOME WAY CONNECTED WITH THE ACCIDENT. FURTHER INFO REGARDING THE ACCIDENT WAS REQUESTED AT THAT TIME, BUT NO FURTHER INFO WAS RECEIVED UNTIL (B)(6) 2014. ON THURSDAY (B)(6) 2014, THE CORONER FOR THE CASE DISCLOSED PHOTOGRAPHS THAT SUGGEST THAT THE HORIZONTAL WELD SECURING THE SEATPOST BASE TO THE MAIN SEAT SUPPORT ASSEMBLY OF THE STAIRLIFT HAD BROKEN. AFTER RECEIVING THE PHOTOGRAPHS, A NUMBER OF FURTHER REQUESTS BY ACORN (B)(4) TO THE CORONER'S OFFICE WERE MADE REQUESTING AN INSPECTION OF THE STAIRLIFT CONCERNED IN ORDER TO ASSIST IN DETERMINING A CAUSE OF THE FAILURE. AT THE TIME OF WRITING, ACORN (B)(4) HAS STILL NOT ATTENDED AN INSPECTION NOR BEEN PROVIDED WITH ANY OTHER KEY FACTS SURROUNDING THIS ACCIDENT (INCLUDING WHETHER THE STAIRLIFT WAS BEING USED IN ACCORDANCE WITH ITS INSTRUCTIONS AND RECOMMENDATIONS FOR USE). NEVERTHELESS, AS A RESULT OF THE RECEIPT OF THESE PHOTOGRAPHS AND THE EXISTENCE OF ONE ADD'L INCIDENT (SEE MEDWATCH SUBMISSION FOR PT ID (B)(4)). ACORN (B)(4) HAS DECIDED, AS A PRECAUTIONARY MEASURE, 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 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 THE (B)(4). THE TYPE OF SEATPOSTS POTENTIALLY IMPLICATED IN THESE INCIDENTS WERE USED IN APPROX OTHER THAN THE (B)(4). THE TYPE OF SEATPOSTS POTENTIALLY IMPLICATED IN THESE INCIDENTS WERE USED IN APPROX (B)(4) STAIRLIFT, MANUFACTURED BETWEEN THE DATES OF (B)(6) 2007 - (B)(6) 2011 AND DISTRIBUTED WORLDWIDE. THE STAIRLIFTS CAN BE IDENTIFIED BY UNIQUE SERIAL NUMBERS (B)(4).