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

Model Number 180 T565 LH USA

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Hyperextension (4523)

Event Date 10/16/2023

Event Type  Injury  

Event Description

On (b)(6) 2024, an aftercare agent from acorn stairlifts, inc contact customer.During their conversation, customer made aware of the agent that he had an incident several months ago.The customer describe the stairlift stopping intermittenly.Per the customer, the stairlift stopped five steps from the bottom.The customer exited the stairlift and fell down to the bottom.He suffer 2 broken fingers on his left hand, stretched the tendon on his left arm.Surgery was required as the result of his injury.Customer also suffer memory loss and equilibrium due to the injury.

• Brand Name: ACORN STAIRLIFT
• Type of Device: POWER 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 32809-5792 ; 4076500216
• MDR Report Key: 19100006
• MDR Text Key: 340103564
• Report Number: 3003124453-2024-00006
• 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: 04/12/2024

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: 03/19/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 93 KG