ROHO® QUADTRO SELECT® HIG PROFILE¿ CUSHION

Additional Manufacturer Narrative

THE CUSHION WAS NOT RETURNED TO ROHO, INC. FROM THE DISTRIBUTOR. AN EVALUATION COULD NOT BE PERFORMED. THE USER MANUAL INCLUDES A WARNING TO DISCONTINUE USE OF A DEFECTIVE PRODUCT THAT READS AS FOLLOWS: "CHECK SKIN FREQUENTLY, AT LEAST ONCE A DAY. REDNESS, BRUISING, OR DARKER AREAS (WHEN COMPARED TO NORMAL SKIN) MAY INDICATE SUPERFICIAL OR DEEP TISSUE INJURY AND SHOULD BE ADDRESSED. IF THERE IS ANY DISCOLORATION TO SKIN/SOFT TISSUE, STOP USE IMMEDIATELY. IF THE DISCOLORATION DOES NOT DISAPPEAR WITHIN 30 MINUTES AFTER DISUSE, IMMEDIATELY CONSULT A HEALTHCARE PROFESSIONAL. - CHECK INFLATION FREQUENTLY, AT LEAST ONCE A DAY. - DO NOT USE A PRODUCT THAT IS UNDERINFLATED OR OVERINFLATED, BECAUSE 1) THE PRODUCT BENEFITS WILL BE REDUCED OR ELIMINATED, RESULTING IN AN INCREASED RISK TO SKIN AND OTHER SOFT TISSUE." DURING INTERVIEW WITH THE USER, HE STATED HE WAS IN THE HABIT OF PERFORMING THE HAND CHECK AS DESCRIBED IN THE USER MANUAL. THE REPLACEMENT CUSHION HE RECEIVED WAS FUNCTIONING PROPERLY. EVEN THOUGH THE CUSHION WAS NOT RETURNED FOR EVALUATION, THE MOST LIKELY ROOT CAUSE IS DUE TO THE NATURE OF THE NEOPRENE CUSHION WEARING THROUGH USE AND DEVELOPING LEAKS. THIS IS A KNOW FAILURE MODE BUT HAS BEEN DETERMINED TO HAVE A GREATER BENEFIT TO USE THAN THE RISK OF LEAKS PRESENTS. PATCH KITS ALONG WITH INSTRUCTIONS ARE PROVIDED TO THE USERS WITH THE CUSHIONS IN ORDER TO REPAIR SMALL LEAKS AS THEY OCCUR.

Description of Event or Problem

THE USER REPORTED TO HIS DEALER HIS ROHO QUAD SELECT CUSHION HAD DEVELOPED A LEAK AND WAS NOT HOLDING AIR. THE CLIENT STATED HE HAD DEVELOPED A PRESSURE INJURY DUE TO THE LEAKING CUSHION.