MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC ACORN 180; POWERED STAIRWAY CHAIRLIFT

Model Number 180 T565 LH USA

Device Problems Charging Problem (2892); Installation-Related Problem (2965)

Patient Problems Fall (1848); Laceration(s) (1946); Balance Problems (4401)

Event Date 11/18/2023

Event Type  Injury  

Event Description

Customer contacted acorn for service due to beeping noise & blank display.After troubleshoot over the phone, it was determined that service visit is required.While waiting for appointment date, customer's wife walk down the stair backward.When she came to the turn at the bottom of the stair, she fell forward into the steps.Her left shin hit the edge of the step and her skin was cut.She required tape and stitches.

• Brand Name: ACORN 180
• 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; orlando, FL 32809-5792 ; 4076500216
• MDR Report Key: 18325977
• MDR Text Key: 330493879
• Report Number: 3003124453-2023-00019
• Device Sequence Number: 1
• Product Code: PCD
• UDI-Device Identifier: 00150017711598
• UDI-Public: 150017711598
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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
• Date Manufacturer Received: 11/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2023
• 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, CANE.
• Patient Outcome(s): Required Intervention; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 59 KG