LEONARD II RECLINER 814-62 WITH PUSHBUTTON BACK RELEASE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-21 for LEONARD II RECLINER 814-62 WITH PUSHBUTTON BACK RELEASE * manufactured by Nemschoff.

Event Text Entries

[1684704] There were several patients during a period of two months that had difficulties getting out of the recliner chair. Other problems include patients sliding onto the floor because the fabric is slippery, patient's legs getting trapped in between the chair seat and leg rest, and patients unable to find the device to lower the leg rest and trying to push it down with their legs causing the chair to tip over and falling off the recliner. ====================== health professional's impression======================the chair is not stable when the patient shifts their weight or tries to get out and up into a standing position. Many patients and visitors were not clear on how to drop the leg rest down since the recliner has a button instead of a hand crank. It does not appear to be a good chair for hospitalized patients. ==================================================================reporter indicated the recliner textile is durable antimicrobial woven, purple color. There had been 5 compaints during the two months period. The recliners were discarded "because they were unsafe to continue to allow patients to use them. " the patient's weight or anatomy are not believed to be contributed factors in this event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1941728
• MDR Report Key: 1941728
• Date Received: 2010-12-21
• Date of Report: 2010-12-21
• Date of Event: 2010-11-30
• Report Date: 2010-12-21
• Date Reported to FDA: 2010-12-21
• Date Added to Maude: 2010-12-30
• 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
• Reporter Occupation: RISK MANAGER
• 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: LEONARD II RECLINER
• Generic Name: RECLINER CHAIR
• Product Code: FRJ
• Date Received: 2010-12-21
• Model Number: 814-62 WITH PUSHBUTTON BACK RELEASE
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PATIENT
• Device Availability: N
• Device Age: 5 YREARS
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NEMSCHOFF
• Manufacturer Address: 909 NORTH 8TH STREET SHEBOYGAN WI 53081 US 53081

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-12-21