JAY

Description of Event or Problem

THE DEALER REPORTED THAT THE FOAM BASE OF THE CUSHION FLATTENED OUT. THE DEALER STATED THAT THE FOAM LOOKS ABOUT ONE (1)-INCH IN HEIGHT. THE DEALER REQUESTED A REPLACEMENT CUSHION PER THE WARRANTY. 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 9 MONTHS. THE EXPECTED LIFETIME OF A WHEELCHAIR CUSHION IS TWO YEARS. JAY ION CUSHION OWNER'S MANUAL, REV B, 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 ION CUSHION IS DESIGNED TO HELP REDUCE PRESSURE. HOWEVER, NO CUSHION CAN COMPLETELY ELIMINATE SITTING PRESSURE OR PREVENT PRESSURE SORES. THE JAY ION CUSHION IS NOT A SUBSTITUTE FOR GOOD SKIN CARE INCLUDING PROPER DIET, CLEANLINESS, AND REGULAR PRESSURE RELIEF." JAY ZIP CUSHION OWNER'S MANUAL, REV B, 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 DEALER REPORTED THAT THE FOAM BASE OF THE CUSHION FLATTENED OUT. THE DEALER STATED THAT THE FOAM LOOKS ABOUT ONE (1)-INCH IN HEIGHT. THE MOST PROBABLE CAUSE FOR "BOTTOMING OUT" OF A FOAM CUSHION IS DEGRADATION, OR THE FOAM LOSING ITS INTENDED SHAPE DURING END USER USE; THIS MAY RESULT IN THE CUSHION PROVIDING INSUFFICIENT SEATING AND POSITIONING SUPPORT NECESSARY FOR THE END USER'S NEEDS. A DHR REVIEW FOR THIS PRODUCT WAS CONDUCTED AND NO ABNORMALITIES, DEVIATIONS OR NCMR'S RELATED TO THE CLAIM WERE IDENTIFIED IN THE MANUFACTURING PROCESS. AS STATED IN THE JAY ION 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. THE DEALER REQUESTED A REPLACEMENT CUSHION PER THE WARRANTY. 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.