CARE 500 MULTILOCK CARE 500 MULTILOCK RECLINER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-27 for CARE 500 MULTILOCK CARE 500 MULTILOCK RECLINER * manufactured by Ioa Healthcare Furniture.

Event Text Entries

[16738194] A patient was sitting in the chair with the leg rest fully raised. The chair rest "collapsed down on patient". The patient has a new joint prosthesis implant. This specific chair had just been returned to unity after being repaired by the manufacturer. However, there have been multiple chairs that have had the same issue with sudden collapse. One chair was repaired last month and had the foot rest drop again last week. We own 37 chairs and all have had the same issue. The manufacturer was here and changed the frame mechanism on all 37 chairs, including the chair that had already been repaired once. The chairs have been malfunctioning for the last few months. Although all of these chairs are used in our joint replacement center, there were no patients harmed. We have had the casters on these chairs replaced three times now for issues related to steering and locking. In addition, the wheels get dents in them which the manufacturer stated was from the chairs moving while the brakes were on. There are front and back brakes and after an in-service staff now know to put on the front and at least one back brake, otherwise the chair moves when the patient sits down and dents the wheel.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2433545
• MDR Report Key: 2433545
• Date Received: 2012-01-27
• Date of Report: 2012-01-27
• Date of Event: 2011-01-26
• Report Date: 2012-01-27
• Date Reported to FDA: 2012-01-27
• Date Added to Maude: 2012-01-31
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CARE 500 MULTILOCK
• Generic Name: RECLINER
• Product Code: FRJ
• Date Received: 2012-01-27
• Model Number: CARE 500 MULTILOCK RECLINER
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 2 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: IOA HEALTHCARE FURNITURE
• Manufacturer Address: 829 BLAIR ST. THOMASVILLE NC 27360 US 27360

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-01-27