MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC ACORN STAIRLIFT; POWERED STAIRWAY CHAIRLIFT

Model Number 180 T565 LH USA

Device Problem Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Pneumothorax (2012)

Event Date 06/08/2023

Event Type  Injury  

Event Description

Customer rode the stairlift down to the landing and stopped on the bend instead of at the charging station like the customer suppose to.Customer stated that she use the stairlift to get to the front door to retrieve a package.She claimed that her mobility issues prevent her from being able to swivel the seat properly in order to get off safely from the stairlift.As the result of this attempt, customer fell down and hit the table by the front door.Customer suffer collapsed lung, five broken ribs, a bruised knee and a bump on the head.

• Brand Name: ACORN STAIRLIFT
• Type of Device: POWERED STAIRWAY CHAIRLIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC; 7001 lake ellenor dr; orlando FL 32809 5792
• Manufacturer Contact: amanda stahl ; 7001 lake ellenor dr; orlando, FL 32809 ; 4076500216
• MDR Report Key: 19004653
• MDR Text Key: 338929906
• Report Number: 3003124453-2024-00005
• 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: Inspection
• Type of Report: Initial
• Report Date: 03/29/2024

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: 180 T565 LH USA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2023
• 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
• Treatment: WALKER
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 109 KG