MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC 180 T565 LH USA; POWERED STAIRWAY CHAIRLIFT

Device Problem Misassembled During Installation (4049)

Patient Problem Laceration(s) (1946)

Event Date 08/09/2023

Event Type  Injury  

Event Description

Customer reported that the stairlift stop working and while she was sitting on the stairlift, her husband walked up the stairs and tried to move around the stairlift.Her husband lost his balance and fell backwards hitting his head on the rail.User's husband required 7 stitches on the back of his head and 3 stitches on the left elbow.

• Brand Name: 180 T565 LH USA
• 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: 17715235
• MDR Text Key: 323009599
• Report Number: 3003124453-2023-00017
• 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: Repair
• Type of Report: Initial
• Report Date: 09/08/2023

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?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 116 KG