MAUDE Adverse Event Report: ACORN STAIRFLITS, INC ACORN 130; POWERED STAIRWAY CHAIRLIFT

Model Number T700 LH

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

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870); Vertebral Fracture (4520)

Event Date 11/06/2023

Event Type  Injury  

Event Description

Customer's brother in-law called to request service for the stairlift.He claim that the stairlift stop working.He also reported that the stairlift stop and his brother in-law got off from the stairlift and fell down.There were no witnesses.Customer suffered a fractured back and bruised all over his body.

• Brand Name: ACORN 130
• Type of Device: POWERED STAIRWAY CHAIRLIFT
• Manufacturer (Section D): ACORN STAIRFLITS, INC; 7001 lake ellenor dr; orlando, fl FL 32809 5792
• Manufacturer (Section G): 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: 18276983
• MDR Text Key: 329856067
• Report Number: 3003124453-2023-00018
• 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: 12/06/2023

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
• Device Model Number: T700 LH
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2023
• 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, OXYGEN.
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 75 KG