ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION

Additional Manufacturer Narrative

DURING INVESTIGATION, THE RETURNED CUSHION APPEARED WELL WORN AND HEAVILY SOILED. THE VALVE WAS CONFIRMED TO BE MISSING AND WAS NOT RETURNED WITH THE CUSHION. AN ATTEMPT HAD BEEN MADE BY THE USER OR USERS CAREGIVER TO PLUG THE VALVE STEM WITH A FOREIGN MATERIAL TO PREVENT IT FROM LEAKING. THE BARBED VALVES ARE ABLE TO BE REMOVED FROM THE VALVE STEM TUBING WHEN PULLING WITH A REASONABLE AMOUNT OF FORCE. ACCEPTANCE LEVELS IN MANUFACTURING IS MINIMUM 10 POUNDS FORCE TO REMOVE THE VALVE. REMOVAL OF THE VALVE FROM THE TUBING WOULD BE AN OBVIOUS EVENT, THE CUSHION WOULD NOT BE ABLE TO HOLD AIR. THE MOST LIKELY CAUSE TO THE REPORTED FAILURE IS THE USER OR HER CAREGIVER PULLED THE VALVE FROM THE TUBING, POSSIBLY DURING INFLATION, AND DID NOT REPLACE THE VALVE. THE IFU SPECIFICALLY STATES TO CHECK THE CUSHION FOR PROPER INFLATION WITH EACH USE AND TO DISCONTINUE USE IF THE CUSHION IS IMPROPERLY INFLATED. THE USERS CUSHION WAS REPLACED UNDER WARRANTY WITH A NEW CUSHION.

Description of Event or Problem

USER REPORTED THE END OF THE VALVE WAS MISSING. USER STATED SHE KEEPS GETTING PRESSURE ULCERS BUT STATE "WON'T SAY THAT THE CUSHION CAUSED THE ULCERS". THE USER HAS BEEN PLACED ON BEDREST, THE IMPROPERLY INFLATED CUSHION EXACERBATED HER EXISTING PRESSURE INJURY. THE CUSHION WAS RETURNED TO ROHO AND VERIFIED TO HAVE A MISSING VALVE ON (B)(6) 2025.