MAUDE Adverse Event Report: WIELAND DESIGNS INC. SAUDER WIELAND COVE RECLINER, WITH WOOD CAP; CHAIR, MEDICAL

Model Number 53981WP

Device Problem Material Integrity Problem (2978)

Patient Problem Injury (2348)

Event Date 10/08/2015

Event Type  malfunction  

Event Description

The first incident happened on approximately three months ago and since then there have been a total of 4 incidents.There is a sleep lever that is located on the inside of the recliner that sticks out.On the adult medical unit they have lots of elderly patients with sensitive skin.This is the info from the first patient safety report: the patient reached his arm down to grab onto seat cushion and scraped across the handle that sticks out which adjusts across the backrest.On the last incident which occurred approximately 1 month ago, i spoke to the patient.It was an elderly lady that said she was sitting in the chair.She went to bring her arm up from under the blanket and she tore the skin on her arm by hitting the control on the inside of the chair.Approximately three months ago, we met with the engineer from the manufacturer who makes the recliner.This week, we met with a group to discuss issues including staff from the distributor who we get our recliners from.The engineer is going to put a prototype together by either changing the lever by making it recessed or by moving it to the outside of the arm of the recliner so we can trial it.I will keep you posted on how that goes.We have these recliners in other parts of hospital but have not had any issues.It seems to be with the elderly patients with sensitive skin.I created a knowledge sharing document stating if there is a patient with sensitive skin, to place a pillow over the lever until we get things figured out.Manufacturer response for sleep recliner, wieland cove (per site reporter): we are working with the engineer to come up with a solution.

• Brand Name: SAUDER WIELAND COVE RECLINER, WITH WOOD CAP
• Type of Device: CHAIR, MEDICAL
• Manufacturer (Section D): WIELAND DESIGNS INC.; 901 e madison st; goshen, IN 46528
• MDR Report Key: 5350021
• MDR Text Key: 35241183
• Report Number: 5350021
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 53981WP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Other