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

Model Number RET 130 ACORN LH US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Multiple Fractures (4519)

Event Date 05/18/2022

Event Type  Injury  

Manufacturer Narrative

Investigation report- unsigned (signed report will be uploaded once received) work completion report.

Event Description

10/17/2022 customer call in to acorn stairlifts, inc.: the customer called in to request his stairlift to be removed as his wife had passed away and he had no need for it.During this call, the customer communicated that an incident had occurred involving his wife on (b)(6) 2022.Customer account of events: the stairlift was stationary at the bottom of the stairway, he pulled the transfer board down to transfer her from the stairlift to her wheelchair.One side of the transfer board was on the stairlift and the other side was on the wheelchair.The transfer board moved when he transferred his wife to the board and she fell resulting in a broken right radius and right clavicle.She was seen by an orthopedic surgeon.

• Brand Name: ACORN
• 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: patrick connally ; 1204 sunrise court; paso robles 93446 ; 8052577596
• MDR Report Key: 15867090
• MDR Text Key: 304331100
• Report Number: 3003124453-2022-00019
• 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: 11/19/2022

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 ACORN LH US
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 64 KG