MAUDE Adverse Event Report: ACORN STAIRLIFTS 130 ACORN T700 RH USA; POWER STAIRLIFT

Device Problem No Apparent Adverse Event (3189)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/30/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, customer notify acorn stairlifts that their daughter came out of their bedroom at the top of the stairs and tripped over the stairlift rail.She then fell down the stairs.At that time she stated the incident occurred about 10 days prior and that ther daughter was in the hospital for three days.She had scrapes on her neck and her right knee was black and blue.The stairlift was parked at the lower charge station and was not being used when the incident occurred.On (b)(6) 2023, we became aware of additional information that the patient suffered a fractured on her right patella.

• Brand Name: 130 ACORN T700 RH USA
• Type of Device: POWER STAIRLIFT
• Manufacturer (Section D): ACORN STAIRLIFTS; 7001 lake ellenor dr; orlando FL 32809 9262
• Manufacturer Contact: amanda stahl ; 7001 lake ellenor dr; orlando, FL 32809-5792 ; 4076500216
• MDR Report Key: 17699575
• MDR Text Key: 322849746
• Report Number: 3003124453-2023-00015
• 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: 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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 68 KG