MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. BROOKS 130; POWERED STAIRWAY CHAIR LIFT

Model Number RET 130

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bruise/Contusion (1754); Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Attachment #1- incident investigation report.Attachment #2= work completion report.

Event Description

The client contacted acorn stairlifts to schedule service for the stairlift on (b)(6) 2022.Acorn was able to move forward with initial quesitons related to a previous call from acorn to the client where the client stated that she had fallen out of the stairlift due to dizziness.The rider was travelling down the stairs when she got dizzy, fell out of the stairlift and rolled down the stairs.This incident resulted in bruising on jer legs and ribs as well as a 10" laceration that reuiqred stitches on her left arm.She could not recall when this fall occurred.The contributing factor to the fall and injury was that the rider was not using the seat belt which is required to safely ride the stairlift.

• Brand Name: BROOKS 130
• Type of Device: POWERED STAIRWAY CHAIR LIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809
• Manufacturer (Section G): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809
• Manufacturer Contact: melissa field ; 7001 lake ellenor drive; orlando, FL 32809 ; 4076500216
• MDR Report Key: 16011231
• MDR Text Key: 305777311
• Report Number: 3003124453-2022-00023
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RET 130
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 67 KG