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

Model Number 130 ACORN T700 LH USA

Device Problems Electrical /Electronic Property Problem (1198); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bone Fracture(s) (1870); Multiple Fractures (4519); Vertebral Fracture (4520)

Event Date 10/21/2022

Event Type  Injury  

Event Description

Summary of incident: (b)(6) 2022 the customer contacted acorn stairlifts, inc.And reported an incident involving the stairlift.He stated that his wife was riding the stairlift and it stopped half way up.She tried to get the stairlift to go up and down, she stated that she did not know what happened but she tumbled down the stairs.In the investigation interview, it stated that she tried to dismount and fell getting out of the stairlift.The fall resulted in a fractured neck and cracked rib.

Manufacturer Narrative

Attachment #1- incident investigation report.Attachment #2- work completion report.

• 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: 15831505
• MDR Text Key: 303996595
• Report Number: 3003214453-2022-00020
• Device Sequence Number: 1
• Product Code: PCD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A#S-P#N/A
• 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: 11/20/2022

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 ACORN T700 LH USA
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2019
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 78 KG