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

Model Number 130 ACORN T700 RH USA

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

Patient Problem Brain Injury (2219)

Event Date 12/27/2022

Event Type  Injury  

Manufacturer Narrative

Attachments: incident investigation- unsigned as revision to add service history.Signed will be in client file.Work completion report.

Event Description

The user was at the bottom of the stairs leaning over the stairlift.She brought the carriage down the rail to the bottom using the remote.She was unaware of the position of the lift and she, being in the obstruction path, the stairlift ran into her, hitting her head and knocking her down.This resulted in a brain bleed and 5 days in the hospital.

• 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: melissa field ; 7001 lake ellenor drive; orlando, FL 32809 ; 4076500216
• MDR Report Key: 16261635
• MDR Text Key: 308344858
• Report Number: 3003124453-2023-00005
• 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: 01/28/2023

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: 130 ACORN T700 RH USA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2020
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 91 KG