MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. ACORN 180 T565; POWERED STAIRWAY CHAIR LIFT

Model Number T565

Device Problems Electrical /Electronic Property Problem (1198); Failure to Power Up (1476); Battery Problem (2885); Intermittent Loss of Power (4016)

Patient Problems Laceration(s) (1946); Neck Pain (2433); Neck Stiffness (2434)

Event Date 06/27/2022

Event Type  Injury  

Manufacturer Narrative

This incident is a mdr for due diligence.It is unclear of what actually contributed to the client falling.The information given by all parties did not align and different accounts of what may have occurred were documented.Extended investigation time was needed to get more facts from the customer.There ws inadequate and conflicting information to determine what actually occurred and clarity of cause of the incident.This is the reason for exceeded 30 day report.

Event Description

Customer's daughter contacted acorn stairlifts, inc on (b)(6) 2022 to get service follow up for their stairlift.The focus of her account was getting service for the stairlift that had not been used for years and she needed it operational for her mother.During this call, she stated that her mother had taken a fall on (b)(6) 2022 because the she was without a stairlift.It was alleged she fell going upstairs because broken glass was found on the landing.The client's daughter did not want to talk about the details of the fall.It is unclear if the stairlift contributed to the fall.Due to the lead time between calls and visits, the elevation of risk to the customer and that the stairlift not being operational may have/could have contributed to a fall.Upon further investigation, the facts of the timeline are as follows: (b)(6) 2022: customer's daughter called acorn on (b)(6) 2022 to inquire about service for the stairlift.She decided to wait on scheduling service at that time.(b)(6) 2022: customer's daughter called acorn to schedule the service to get the stairlift operating for her mother.Service was conducted however a part needed ot be ordered and a follow up visit needed to be scheduled.According to the information, the customer did not call to be scheduled until (b)(6) 2022.The service was scheduled for (b)(6) 2022.The service was not conducted due to not having the part.

• Brand Name: ACORN 180 T565
• 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: 15452200
• MDR Text Key: 300212625
• Report Number: 3003124453-2022-00014
• 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: 09/17/2022

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: T565
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2016
• 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
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 59 KG