ACORN 120 STRAIGHT STAIRLIFT NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2014-04-02 for ACORN 120 STRAIGHT STAIRLIFT NA manufactured by Acorn Mobility Services Ltd.

Event Text Entries

[20270418] Acorn mobility services ltd. ("acorn (b)(4)") the manufacturing corporation of the medical device concerned, were contacted, in (b)(6) 2013, by the (b)(4)'s coroners office 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 individual in the (b)(6) together with an indication that the stairlift was in some way connected with the accident. Further information regarding the accident was requested at that time, but no further information 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 determinnig 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 surrouinding 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 additional incident (see medwatch submission for patient identified (b)(6)) 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 information acorn (b)(4) has regarding the incidents and tre 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 approximately (b)(4) stairlifts, manufactured between the dates of march 2007, march 2011 and distributed worldwide. (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3006310491-2014-00001
• MDR Report Key: 3871143
• Report Source: 00,01
• Date Received: 2014-04-02
• Date of Report: 2014-04-01
• Date of Event: 2013-07-01
• Date Mfgr Received: 2013-08-23
• Device Manufacturer Date: 2009-10-01
• Date Added to Maude: 2014-06-16
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Street: TELECOM HOUSE MILLENNIUM BUSINESS PARK, STATION ROAD
• Manufacturer City: STEETON BD206RB
• Manufacturer Country: UK
• Manufacturer Postal: BD20 6RB
• Manufacturer Phone: 35291000
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ACORN 120 STRAIGHT STAIRLIFT
• Generic Name: POWERED STAIRWAY CHAIR LIFT
• Product Code: ILK
• Date Received: 2014-04-02
• Model Number: ACORN 120
• Catalog Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ACORN MOBILITY SERVICES LTD
• Manufacturer Address: TELECOM HOUSE MILLENNIUM BUSINESS PARK, STATION ROAD STEETON B0206RB UK B020 6RB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2014-04-02