MAUDE Adverse Event Report: ACORN STAIRLIFTS INC ACORN 180; STAIRWAY CHAIRLIFT

Model Number ACORN 180 RH

Device Problems Use of Device Problem (1670); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 03/01/2013

Event Type  malfunction  

Event Description

User was riding stairlift in downward direction.After making the first turn the seat base broke off from the seat and the user fell onto the stairs and slid down the last few steps of the lower flight.User bumped her head and bruised the back of her legs.

Manufacturer Narrative

User reported that she did not always swivel at the top putting extra pressure on the lateral seat connectors.Most likely underlying cause was the extra pressure causing the seat to pull away from the base connector.Seat was replaced and broken seat returned to fl warehouse.Seat was scrapped for parts.Proper investigation report not completed.Process reviewed and updated by management.Full tracking of all rma's with reconciliation reports included now implemented.

• Brand Name: ACORN 180
• Type of Device: STAIRWAY CHAIRLIFT
• Manufacturer (Section D): ACORN STAIRLIFTS INC; orlando FL
• Manufacturer Contact: tracy bero ; 7335 lake ellenor drive; orlando, FL 32809 ; 4076500216
• MDR Report Key: 4317123
• MDR Text Key: 5137065
• Report Number: 3003124453-2014-00014
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ACORN 180 RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2013
• Initial Date FDA Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR