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

Model Number 180 T565 LH

Device Problem Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)

Event Date 09/27/2022

Event Type  Injury  

Event Description

On (b)(4) 2022, the client contacted acorn stairlifts, inc.(acorn) for service on the stairlift.His account of the incident was: on (b)(6) 2022, his wife fell from the stairlift after it stopped unexpectedly.She fell off the stairlfit and down the remaining steps.She required surgery that included screws to her right side thigh and hip.After the surgery, she was sent to rehab.

Manufacturer Narrative

The root cause of this incident was the user not sitting back in the proper riding position, causing extra stress to be put on the top rollers and osg over time which caused irregular/excessive premature wear to the top rollers and osg.This caused the osg to engage.The user also contributed to the incident by using the stairlift out of specification when using it without wearing the seatbelt.At the time of installation a user manual indicating the seat belt must be worn to operate the stairlift was left with the customer.Had the user been riding in the proper riding position and the seat belt been worn, when the osg engaged and the stairlift stopped the user would have remained on the seat.

• Brand Name: ACORN 180 T565
• 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: 15860844
• MDR Text Key: 304282985
• Report Number: 3003124453-2022-00018
• 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: 11/24/2022

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 Model Number: 180 T565 LH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2019
• 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): Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 86 KG