MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. ACORN 180 T565 LH; POWERED STAIRWAY CHAIRLIFT

Device Problems Improper or Incorrect Procedure or Method (2017); Installation-Related Problem (2965)

Patient Problem Hip Fracture (2349)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Customer's husband, mr.(b)(6), called in on (b)(6) 2019 to request a service visit.During that call, he mentioned an incident that occured sometime in (b)(6) of 2018, exact date was unknown.Mr.(b)(6) stated that his wife was traveling down the stairs when the lift stopped at the 2nd step from the bottom.He stated that because his wife was not wearing her seatbelt, she fell out of the chair and down the stairs.

Event Description

Sometime in (b)(6) of 2018, exact date unknown, customer was riding the lift downstairs.Customer's husband claimed that the lift unexpectedly stopped when she got to the 2nd step from the bottom.Customer was not wearing her seatbelt and fell out of the chair and down remaining stairs and broke her hip.

• Brand Name: ACORN 180 T565 LH
• Type of Device: POWERED STAIRWAY CHAIRLIFT
• Manufacturer (Section D): ACORN STAIRLIFTS, INC.; 7001 lake ellenor drive; orlando FL 32809 5792
• Manufacturer Contact: tracy bero ; 7001 lake ellenor drive; orlando, FL 32809-5792 ; 4072308879
• MDR Report Key: 8723356
• MDR Text Key: 148807283
• Report Number: 3003124453-2019-00004
• 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: Repair
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2017
• 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: 81 YR
• Patient Weight: 54