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

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Laceration(s) (1946)

Event Date 04/20/2023

Event Type  Injury  

Event Description

Stairlift was inoperable so the client (mh) decided to walk the steps, lost her balance and fell.Customer suffered head laceration that required stitches.

• Brand Name: ACORN 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 (Section G): ACORN STAIRLIFTS, INC.; 7001 lake ellenor dr; orlando FL 32809 5792
• Manufacturer Contact: amanda stahl ; 7001 lake ellenor dr; orlando, FL 32809-5792 ; 4076500216
• MDR Report Key: 17238700
• MDR Text Key: 318267053
• Report Number: 3003124453-2023-00012
• 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: 06/28/2023

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: 04/21/2023
• Initial Date FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2019
• 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
• Treatment: WALKER, WHEELCHAIR
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 54 KG