ROHO QUADTRO SELECT HIGH PROFILE CUSHION

Additional Manufacturer Narrative

THE USER CALLED ROHO FOR A WARRANTY REPLACEMENT OF HER ROHO QUAD SELECT QS89 CUSHION DUE TO THE CUSHION NOT HOLDING AIR. THE USER STATED SHE NOTICED THE CUSHION WAS NOT HOLDING AIR DURING A DOCTORS APPOINTMENT A COUPLE OF WEEKS PRIOR TO THE CALL. SHE REQUESTED A REPLACEMENT BECAUSE SHE HAD PRESSURE SORE INJURIES. THE USER DID NOT SPECIFY IF THE PRESSURE SORE WAS A RESULT OF THE LEAKING CUSHION OR IF THE DOCTOR APPOINTMENT WAS IN RELATION TO THE PRESSURE SORES. AT THE TIME OF THIS SUBMISSION, ROHO HAS BEEN UNSUCCESSFUL WITH ESTABLISHING CONTACT WITH THE USER. SINCE THE SEVERITY OF THE PRESSURE SORES AND THE RELATION OF THE PRESSURE SORES TO THE LEAKING CUSHION COULD NOT BE ESTABLISHED, ROHO IS REPORTING THIS AS A POTENTIAL SERIOUS INJURY. THERE ARE NO INDICATIONS OF ANY MANUFACTURING ISSUES WHEN REVIEWING THE DHR. THIS CUSHION LEAKED AFTER APPROXIMATELY A YEAR OF USAGE. EACH CUSHION IS SHIPPED WITH A PATCH/REPAIR KIT WITH INSTRUCTIONS FOR USERS TO PATCH THEIR CUSHIONS IF MINOR LEAKS OCCUR. THIS USER DID NOT GIVE ANY INDICATION IF SHE HAD ATTEMPTED TO REPAIR THE LEAK IN HER CUSHION PRIOR TO REQUESTING A WARRANTY REPLACEMENT. ROHO WILL CONTINUE TO ATTEMPT TO ESTABLISH CONTACT WITH THE USER AND WILL UPDATE THIS REPORT IF ANY FURTHER RELEVANT INFORMATION IS DISCOVERED.

Description of Event or Problem

USER CALLED IN WITH A COMPLAINT THAT HIS QS89C CUSHION IS LEAKING. SHE HAS A PRESSURE SORE INJURY.