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

Model Number 180 T565 RH USA

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Bone Fracture(s) (1870); Vertebral Fracture (4520)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

The full investigation report is on file with acorn stairlifts, inc.

Event Description

Acorn stairlifts, inc received a call from the client on 2.07.2023 for service of his stairlift.During the conversation, the client communicated that on (b)(6) 2023, he had taken a fall trying to get into the stairlift.The stairlift was at the top landing, the client attempted to get into the stairlift, hisleft missed the footrest on the stairlift and he stepped off the top step.He fell 22 stairs resulting in c3 fracture.The client also communicated that he had taken multiple falls over a short time; 4 falls in two months as he was also in the midst of battling covid.He stated he was in a daze and having memory and balance challenges during this time.

• Brand Name: ACORN
• 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: 16484830
• MDR Text Key: 310684312
• Report Number: 3003124453-2023-00011
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/05/2023

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: 180 T565 RH USA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2019
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 68 KG