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

Model Number ACORN 130 T700

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

Patient Problems Stroke/CVA (1770); Bone Fracture(s) (1870); Head Injury (1879); Brain Injury (2219); Vertebral Fracture (4520)

Event Date 01/30/2023

Event Type  Death  

Event Description

Acorn stairlifts, inc.Received an incident call on (b)(6) 2023.The daughter of the rider communicated that her father had taken a fall after getting off of the stairlift.On (b)(6) 2023, the rider rode the stairlift upstairs to the landing.He did completely and safely dismount the stairlift onto the landing.He turned toward the stairs and activated the stairlift to go back down the stairs via the remote.The stairlift moved to the bottom of the stairs.The client mis-stepped or slipped, falling forward down the stairs, his head hitting the stairlift rail and his body landing on the seat of the stairlift.The fall resulted in c1 vertebrae fracture, facial fractures and brain injury.On (b)(6) 2023, he passed due to his injuries.Specifically, a stroke that resulted from the brain injury according to his daughter.

Manufacturer Narrative

Attachment 1_work completion report- summarizes service, inspection, inspection results and communication with client.Attachment 2- investigation report - incident details, investigation, root cause, remedial action as applicable.Signed iir (incident investigation report) is on file.

• Brand Name: ACRON
• 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: 16483502
• MDR Text Key: 310673974
• Report Number: 3003124453-2023-00010
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA#S-P#NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/04/2023

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: ACORN 130 T700
• Device Catalogue Number: N/A
• Device Lot Number: N.A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• 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): Death
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 91 KG