MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. ACORN 180 T565; POWERED STAIRWAY CHAIR LIFT

Model Number 180 T565 RH USA

Device Problems Failure to Charge (1085); Use of Device Problem (1670); Battery Problem (2885)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/11/2022

Event Type  Injury  

Manufacturer Narrative

Incident investigation report.Work completion report.

Event Description

Client contacted acorn stairlifts, inc.(acorn) on (b)(6) 2022.The client communicated that her husband was walking up the stairs and had fallen on (b)(6) 2022 resulting in three broken ribs on his left side.

• Brand Name: ACORN 180 T565
• 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: 16119363
• MDR Text Key: 306880026
• Report Number: 3003124453-2023-00002
• 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: Repair
• Type of Report: Initial
• Report Date: 01/07/2023

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: 12/12/2022
• Initial Date FDA Received: 01/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 75 KG