ACORN 130 RH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-01-27 for ACORN 130 RH manufactured by Acorn Stairlifts, Inc..

Event Text Entries

[66005927] Root cause of hinge strut becoming loose was gasket inside strut losing integrity, releasing pressure.
Patient Sequence No: 1, Text Type: N, H10

[66005928] Client was picking up bags off the floor and hinged rail came down and hit her knee. Fractured patella.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003124453-2017-00003
• MDR Report Key: 6283982
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2017-01-27
• Date of Report: 2017-01-27
• Date of Event: 2016-11-09
• Date Mfgr Received: 2016-12-29
• Device Manufacturer Date: 2016-08-16
• Date Added to Maude: 2017-01-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: SERVICE AND TESTING PERSONNEL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. TRACY BERO
• Manufacturer Street: 7001 LAKE ELLENOR DRIVE
• Manufacturer City: ORLANDO FL 32809
• Manufacturer Country: US
• Manufacturer Postal: 32809
• Manufacturer Phone: 4076500216
• Single Use: 3
• Remedial Action: IN
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ACORN 130 RH
• Generic Name: POWERED STAIRWAY CHAIRLIFT
• Product Code: PCD
• Date Received: 2017-01-27
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ACORN STAIRLIFTS, INC.
• Manufacturer Address: 7001 LAKE ELLENOR DRIVE ORLANDO FL 32809 US 32809

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2017-01-27