MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. 130 ACORN T700 RH USA; POWERED STAIRWAY CHAIR LIFT

Model Number 130 T700 RH

Device Problem Human-Device Interface Problem (2949)

Patient Problem Laceration(s) (1946)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

Attachments: investigation report, work completion report.

Event Description

On (b)(6) 2021.The customer contacted acorn stairlifts, inc.(acorn) because the upper safety cover on the stairlift was loose.On (b)(6) 2021, the customer contacted acorn to communicate hat his wife had fallen using the stairs.Specifically, the incident occurred on (b)(6) 2021 after he contacted acorn about the safety cover being loose.His account is that his wife was walking down the stairs, she fell and she was wedged under the rail resulting in stitches in both arms, both knees and her left hip.The customer did claim that the stairlift was not working at the time of the incident.

• Brand Name: 130 ACORN T700 RH USA
• 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: ms. ; 7001 lake ellenor dr; orlando, FL 32809 ; 4076500216
• MDR Report Key: 15175420
• MDR Text Key: 297338608
• Report Number: 3003124453-2022-00008
• 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: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 08/05/2022

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: 130 T700 RH
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/02/2021
• Initial Date FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2018
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 72 KG