MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. 130 ACORN T700 LH; POWER STAIRWAY CHAIR LIFT

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

Patient Problems Abrasion (1689); Bone Fracture(s) (1870); Laceration(s) (1946); Paralysis (1997)

Event Date 08/17/2020

Event Type  Death  

Manufacturer Narrative

On (b)(6) 2020, the customer's son-a-law informed an acorn customer support agent of the customer's injuries; however, the complaint was not accurately documented.The designated complaint handling team was not aware of the adverse event until 11/17/2020 when an acquaintance of the customer informed acorn of the customer's death.Acorn is not able to determine the root cause of the stairlift not working on (b)(6) 2020.Acorn does not believe there was a product malfunction.On (b)(6) 2020, the son-in-law stated: the customer had the stairlift for eight months and hasn't had a problem going up or down the rail.The stairlift was displaying a c6 code (meaning the stairlift was on a charge point fully charged).When the carriage was moving down the rail it displayed a3 (carriage moving down with the toggles).All the above imply the stairlift was operating within specifications on (b)(6) 2020.On (b)(6) 2020, the son-in-law stated the stairlift was working and they (the family) have used it a couple of times since the incident on (b)(6) 2020.Acorn inspected the stairlift on 11/19/2020 and found the stairlift operating within specifications.The most likely cause of the stairlift not working on (b)(6) 2020 was user error; however, acorn is not able to determine the source of the user error.The stairlift was installed on (b)(6) 2020 and at the time of install, the customer signed a work report stating he received a demonstration of proper stairlift use.Acorn also has a picture of a user manual and quick user guide being provided to the customer on (b)(6) 2020.Acorn was not able to speak to the customer about the incident and the son-in-law was not present at the time of the incident.

Event Description

The customer was attempting to use the stairlift on (b)(6) 2020 to go upstairs.He was not able to get the stairlift to move so he walked up the stairs.At the top, he slipped falling backwards sustaining several serious injuries.He was taken to the hospital where he underwent surgery but became paralyzed as a result.According to the customer's son-in-law, the customer died because of his injuries on (b)(6) 2020.

• Brand Name: 130 ACORN T700 LH
• Type of Device: POWER 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: dorian pearson-shaver ; 7001 lake ellenor drive; orlando, FL 32809 ; 4076500216
• MDR Report Key: 11154990
• MDR Text Key: 226268783
• Report Number: 3003124453-2021-00001
• 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: 01/08/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• 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: CANE
• Patient Outcome(s): Death
• Patient Age: 91 YR
• Patient Weight: 79