ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION

Additional Manufacturer Narrative

MANUFACTURING EVALUATION OF BOTH THE ORIGINAL COMPLAINT CUSHION AND THE REPLACEMENT CUSHION WERE UNABLE TO IDENTIFY ANY MANUFACTURING DEFECTS WITH THE CUSHIONS. INTERVIEWS WITH THE USER IDENTIFIED USAGE ERROR AS THE MOST LIKELY ROOT CAUSE. THE USER IDENTIFIED HE FREQUENTLY LEANS TO ONE SIDE IN HIS CHAIR. BY USING A SINGLE CHAMBER AIR CUSHION, LEANING TO ONE SIDE CAUSES THE AIR TO DISPLACE, ALLOWING THE USER TO BOTTOM OUT ON THE LEANING SIDE. SINCE THE USER WAS IDENTIFIED TO BE USING THE WRONG TYPE OF CUSHION, HE WAS RECOMMENDED TO RETURN TO HIS CLINICIAN FOR RE-EVALUATION OF THE TYPE OF CUSHION HE SHOULD BE USING.

Description of Event or Problem

USER HAS REPORTED HIS CUSHION LEAKS WITHIN ABOUT 30 MINUTES OF INFLATION, CAUSING HIM TO BOTTOM OUR IN HIS WHEELCHAIR.