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

[16802930] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006310491-2014-00002
MDR Report Key3872990
Report Source00,01
Date Received2014-04-02
Date of Report2014-04-01
Date of Event2013-09-25
Date Mfgr Received2014-09-27
Device Manufacturer Date2007-10-01
Date Added to Maude2014-06-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer StreetTELECOM HOUSE MILLENNIUM BUSINESS PARK, STATION ROAD
Manufacturer CitySTEETON BD206RB
Manufacturer CountryUK
Manufacturer PostalBD20 6RB
Manufacturer Phone35291000
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACORN 120 STRAIGHT STAIRLIFT
Generic NamePOWERED STAIRWAY CHAIR LIFT
Product CodeILK
Date Received2014-04-02
Model NumberACORN 120
Catalog NumberNA
Lot NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerACORN MOBILITY SERVICES LTD
Manufacturer AddressTELECOM HOUSE MILLENNIUM BUSINESS PARK, STATION ROAD STEETON BD206RB UK BD20 6RB


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2014-04-02

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