ACORN 180 RH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-10-14 for ACORN 180 RH manufactured by Acorn Stairlifts, Inc..

Event Text Entries

[57549777] Client was still connected to her oxygen cannister when she tried to ride the lift.
Patient Sequence No: 1, Text Type: N, H10

[57549778] Client using lift to come downstairs. Client was not using seatbelt. She reports that the lift jerked and she fell to the floor breaking her nose.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003124453-2016-00007
• MDR Report Key: 6031293
• Report Source: CONSUMER
• Date Received: 2016-10-14
• Date of Report: 2016-10-14
• Date of Event: 2016-09-11
• Date Mfgr Received: 2016-09-15
• Device Manufacturer Date: 2016-05-24
• Date Added to Maude: 2016-10-14
• 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: PATIENT
• 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 180 RH
• Generic Name: POWERED STAIRWAY CHAIRLIFT
• Product Code: PCD
• Date Received: 2016-10-14
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• 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	2016-10-14