MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. 180 T565 RH; POWERED STAIRWAY CHAIR LIFT

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

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 06/27/2021

Event Type  Injury  

Manufacturer Narrative

Acorn spoke with the daughter on 7/19/2021 for clarification on how the rag became caught on the rail.The daughter stated that her father just got home from the hospital on (b)(6) 2021 (for an unrelated issue) and was riding the stairlift upstairs.The user forgot his medicine so he reverse directions to go back down.When he got to the cabinet at the bottom of the stairs, he reach out for the medicine and fell forward.A rag was used for his injuries after the accident and was left on the rail.Sometime after the incident, someone drove the stairlift upstairs catching the rag on the way up.The user failed to use the stairlift as intended.The stairlift is intended to take users the entire length of the rail (from charge point to charge point) without interruption.When the user interrupted his travel to grab his pills off the cabinet at the bottom of the stairs, he stopped the stairlift's intended used.The user most likely was not wearing his seatbelt at the time of the accident because the seatbelt is designed to keep users in the seat.At the time of installation, acorn demonstrated the stairlift to the user's daughter.Acorn also provided the user with an acorn 180 curved stairlift user manual, which outlines proper stairlift usage.Acorn will send the user an out of specification letter to remind them always sit back in the chair with the seatbelt on while using the stairlift.Acorn has also sent a demonstration video to the user's daughter, who has stated she will show the video to her father and all his caregivers.

Event Description

The wife of the user contacted acorn stairlifts, inc.(acorn) on (b)(6) 2021 requesting service for her stairlift because a rag was caught in the rail and the stairlift was not working.During the phone call, the wife reported that her husband fell; however, she did not allege that the stairlift was involved with her husband's accident.Later that same day the daughter contacted acorn again requesting service (a service visit was setup during the first call).The daughter reported that her father was using the stairlift the day before, when he fell out while reaching for something.The user was taken to the hospital for treatment.Acorn contacted the wife of the user on (b)(6) 2021 to follow up about her husband's injuries.The wife stated her husband had a broken right femur, bruised head, cut forehead, chipped kneecap, and the skin on his right arm was removed from his elbow to wrist.The user required surgery.

• Brand Name: 180 T565 RH
• 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: dorian pearson-shaver ; 7001 lake ellenor drive; orlando, FL 32809 ; 4076500216
• MDR Report Key: 12249280
• MDR Text Key: 268063538
• Report Number: 3003124453-2021-00016
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/29/2021

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2020
• 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): Hospitalization
• Patient Age: 99 YR
• Patient Weight: 54