JAY SEATING CUSHION

Description of Event or Problem

THE DEALER REPORTS THAT THE END USER INFORMED HER THAT THE SEATED PART OF THE CUSHION IS SINKING IN AND IS UNCOMFORTABLE. THE DEALER HAS REQUESTED A WARRANTY FOR THIS CUSHION. NO USER INJURIES OR ADVERSE IMPACT WERE REPORTED.

Additional Manufacturer Narrative

BACKGROUND INFORMATION: THE AGE OF THE WHEELCHAIR CUSHION AT THE TIME OF THE COMPLAINT WAS APPROXIMATELY 1 YEAR AND 6 MONTHS. THE EXPECTED LIFETIME OF A WHEELCHAIR CUSHION IS 2 YEARS. JAY UNION CUSHION OWNER'S MANUAL, REV A, PAGE 2 STATES: "WARNING! PRIOR TO PROLONGED SITTING, ANY CUSHION SHOULD BE TRIED FOR A FEW HOURS AT A TIME WHILE A CLINICIAN INSPECTS YOUR SKIN TO ENSURE THAT RED PRESSURE SPOTS ARE NOT DEVELOPING. YOU SHOULD REGULARLY CHECK FOR SKIN REDNESS. THE CLINICAL INDICATOR FOR TISSUE BREAKDOWN IS SKIN REDNESS. IF YOUR SKIN DEVELOPS REDNESS, DISCONTINUE THE USE OF THE CUSHION IMMEDIATELY AND SEE YOUR DOCTOR OR THERAPIST. THE JAY UNION CUSHION IS DESIGNED TO HELP REDUCE PRESSURE. HOWEVER, NO CUSHION CAN COMPLETELY ELIMINATE SITTING PRESSURE OR PREVENT PRESSURE SORES. THE JAY UNION CUSHION IS NOT A SUBSTITUTE FOR GOOD SKIN CARE INCLUDING PROPER DIET, CLEANLINESS, AND REGULAR PRESSURE RELIEF." JAY UNION CUSHION OWNER'S MANUAL, REV A, PAGE 3 STATES: "EASY MAINTENANCE & CLEANING: REGULAR CLEANING AND MAINTENANCE MAY HELP EXTEND THE LIFE OF YOUR CUSHION. DURING CLEANING, COMPONENT INSPECTION IS RECOMMENDED. CHECK THE COVER FOR TEARS AND EXCESSIVE WEAR AND/OR ANY OTHER ABNORMALITIES. CHECK THE FOAM BASE TO ENSURE FOAM CONSISTENCY." DISCUSSION: THE MOST PROBABLE CAUSE FOR "BOTTOMING OUT" FOR A FOAM CUSHION IS DEGRADATION, OR THE FOAM LOSING ITS INTENDED SHAPE WHEN BEING USED BY THE END USER. THIS MAY CAUSE THE CUSHION TO NO LONGER PROVIDE SUFFICIENT SEATING AND POSITIONING SUPPORT NECESSARY FOR THE USER'S SPECIFIC NEEDS. THE DEALER REPORTS THAT THE END USER INFORMED HER THAT THE SEATED PART OF THE CUSHION IS SINKING IN AND IS UNCOMFORTABLE. AS STATED IN THE JAY UNION CUSHION OWNER'S MANUAL, THE CUSHION SHOULD BE INSPECTED TO CHECK FOR ABNORMALITIES TO THE FOAM CONSISTENCY. IF PROPER SUPPORT IS NOT BEING PROVIDED, THE END USER SHOULD DISCONTINUE USING THE CUSHION AND IMMEDIATELY CONTACT THEIR SUNRISE MEDICAL SUPPLIER. CONCLUSION: THE INFORMATION IN THE COMPLAINT INDICATES A REDUCTION OF PRESSURE RELIEVING CAPABILITIES IN THE PELVIC WELL AREA RELATED TO DEFORMATION OF THE FOAM MATERIAL. THE REPORTED EVENT IS MOST LIKELY A PRODUCT MALFUNCTION. THE PRODUCT IN QUESTION MET ALL PRODUCT SPECIFICATIONS BEFORE RELEASE FOR DISTRIBUTION AT THE TIME OF SHIPPING TO THE CUSTOMER. THE RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE FOR FAILING TO MEET LIFE EXPECTANCY IS NOT KNOWN. THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE FAILURE MODE HAS BEEN PREVIOUSLY REPORTED PER 21 CFR 803.50.

Description of Event or Problem

THIS REPORT REPRESENTS A CORRECTION TO A PREVIOUSLY SUBMITTED MDR.

Additional Manufacturer Narrative

THIS MDR ONLY CONTAINED THE DI PORTION OF THE UDI INCLUDED IN THE MEDWATCH FORM. THE MDR HAS BEEN CORRECTED BY ADDING THE FULL UDI NUMBER.