MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. RET 130 ACORN LH US; POWERED STAIRWAY CHAIR LIFT

Catalog Number RET 130

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/29/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Acorn stairlifts, inc.Was made aware of an adverse event on (b)(6) 2021.Client account of events: client stated that his mother was riding the stairlift up the stairs, the stairlift stopped mid-travel.The rider got off the stairlift and fell down the stairs resulting in broken ribs.She was hospitalized for a week.

• Brand Name: RET 130 ACORN LH US
• 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: 15397591
• MDR Text Key: 299667332
• Report Number: 3003124453-2022-00013
• 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: 09/10/2022

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 Catalogue Number: RET 130
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 09/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2018
• 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): Hospitalization; Other
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 73 KG