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

Model Number 180 T565

Device Problem Use of Device Problem (1670)

Patient Problems Bruise/Contusion (1754); Brain Injury (2219); Multiple Fractures (4519)

Event Date 10/20/2022

Event Type  Injury  

Manufacturer Narrative

Incident investigation report and work completion report are attached.

Event Description

Customer account summary: on (b)(6) 2022, the rider was riding the stairlift down stairs.The stairlift slowed down at the 90 degree bend, the rider thought she was at the bottom and released the toggle bringing the stairlift to a full stop.Not realizing she was not at the bottom, she proceeded to got off of the stairlift and fell down to the floor landing on her face.She was placed in icu for brain bleed and multiple unspecified fractures.

• Brand Name: ACORN 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: 15912610
• MDR Text Key: 304787068
• Report Number: 3003124453-2022-00022
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA#S-P#NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/04/2022

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: 180 T565
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 12/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2022
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 93 YR
• Patient Sex: Female
• Patient Weight: 49 KG