MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC ACORN 120; STAIRWAY CHARLIFT

Model Number ACORN 120 RH

Device Problem Installation-Related Problem (2965)

Patient Problems Fall (1848); No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2012

Event Type  malfunction  

Event Description

Customer, an amputee, was transitioning from his wheelchair to the stairlift and when he slid onto the seat it tilted and customer fell down the steps.No injuries reported.

Manufacturer Narrative

Chair tilted approx 7 degrees to the downside when client was transferring from his wheelchair.He lost his balance and fell down six steps.Root cause was seat post bolts and shifted over time due to not following proper installation and service protocol to torque to specification.Corrective action - field techs supplied with calibrated torque wrench and trained in correct use.Annual calibration process to ensure proper standardized calibration.

• Brand Name: ACORN 120
• Type of Device: STAIRWAY CHARLIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC; orlando FL
• Manufacturer Contact: tracy bero ; 7335 lake ellenor drive; belle isle, FL 32809 ; 4076500216
• MDR Report Key: 4317142
• MDR Text Key: 5137067
• Report Number: 3003124453-2014-00012
• 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: Other
• Type of Report: Initial
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ACORN 120 RH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• 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
• Treatment: WHEELCHAIR,
• Patient Outcome(s): Other