JAY FLUID PAD

Report

Report Number: 9616084-2021-00048
Event Type: Malfunction
Date Received: August 13, 2021
Date of Event: August 7, 2020
Report Date: August 13, 2021
Manufacturer: SUNRISE MEDICAL (US) LLC
Product Code: KNN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

BACKGROUND INFORMATION: SUNRISE CUSHIONS HAVE VARIOUS TYPES OF FILLS (E.G., AIR, FLUID, GEL, FOAM). A COMMON COMPLAINT (MALFUNCTION) IS THE PRESENCE OF AIR IN THE FLUID AND/OR GEL CUSHIONS. WHILE THIS IS CONSIDERED A MALFUNCTION, TO BE CLEAR, THERE IS NO INCREASED LIKELIHOOD OF INJURY DUE TO THE PRESENCE OF AIR IN THE FLUID AND/OR GEL CUSHIONS. AIR IS ALSO CONSIDERED AN ACCEPTABLE CUSHIONING AGENT THAT HELPS TO PREVENT PRESSURE SORES IF USED APPROPRIATELY ALONG WITH PRESSURE RELIEF AND PROPER SKIN MONITORING AND MAINTENANCE. NO CUSHION WILL PREVENT PRESSURE SORES WITHOUT THE COOPERATION AND ACTIVE INVOLVEMENT OF THE USER AND/OR CAREGIVERS. FOGELBERG, ATKINS, BLANCHE, CARLSON, AND CLARK (DECISIONS AND DILEMMAS IN EVERYDAY LIFE: DAILY USE OF WHEELCHAIRS BY INDIVIDUALS WITH SPINAL CORD INJURY AND THE IMPACT ON PRESSURE ULCER RISK. TOPICS IN SPINAL CORD INJURY REHABILITATION, 15(2), 16- 32. DOI: 10.1310/SCI1502-16) DETERMINED THAT THE LIFETIME INCIDENCE, IN INDIVIDUALS THAT USE WHEELCHAIRS DUE TO SPINAL CORD INJURIES, HAVE A 95% CHANCE OF DEVELOPING A PRESSURE SORE/INJURY/ULCER. THIS IS PRIMARILY DUE TO THE FACT THAT FULL-TIME WHEELCHAIR USERS MUST PERFORM ALL DAILY ROUTINES WHILE CONFINED TO A SEATED POSITION FOR MOST WAKING HOURS. DUE TO LACK OF PHYSICAL SENSATION, PERSONS WITH THESE IMPAIRMENTS MAY NOT MOVE THEIR POSITIONS OFTEN ENOUGH TO REMOVE PRESSURE FROM AREAS OF RISK (E.G., AREAS OVER BONY PROMINENCES SUCH AS THE SACRUM, COCCYX, TROCHANTERS, ETC.) TO ALLOW FOR CONTINUOUS BLOOD CIRCULATION TO THE SKIN OVERLYING THESE STRUCTURES. AS A RESULT, SKIN BREAKDOWN CAN OCCUR. THERE ARE FOUR LEVELS OF PRESSURE SORES: STAGE 1: THIS IS THE MILDEST STAGE. THESE PRESSURE SORES ONLY AFFECT THE UPPER LAYER OF SKIN. SYMPTOMS MAY INCLUDE PAIN, BURNING, OR ITCHING. THE SPOT MAY ALSO FEEL DIFFERENT FROM SURROUNDING SKIN: FIRMER OR SOFTER, WARMER OR COOLER. THE SKIN MAY ALSO LOOK REDDENED OR MAY GET NOT GET LIGHTER WHEN YOU PRESS ON IT (BLANCH) OR EVEN 10-30 MINUTES AFTER PRESSURE IS REMOVED. THIS MAY REQUIRE GENTLE SKIN CLEANING AND CARE, BUT NO MEDICAL INTERVENTION IS REQUIRED. STAGE 2: SKIN IS BROKEN, LEAVES AN OPEN WOUND, OR LOOKS LIKE A PUS-FILLED BLISTER. THE AREA IS SWOLLEN, WARM, AND/OR RED. THE SORE MAY OOZE CLEAR FLUID OR PUS. THIS REQUIRES WOUND TREATMENT, BUT MAY NOT REQUIRE MEDICAL INTERVENTION UNLESS PATIENT OR CAREGIVER IS UNABLE TO PERFORM ROUTINE WOUND CARE. THE WOUND IS PAINFUL (IN NON-PLEGICS). STAGE 3: THESE SORES HAVE GONE THROUGH THE SECOND LAYER OF SKIN INTO THE FAT TISSUE. THE SORE LOOKS LIKE A CRATER AND MAY HAVE A BAD ODOR. IT MAY SHOW SIGNS OF INFECTION: RED EDGES, PUS, ODOR, HEAT, AND/OR DRAINAGE. THE TISSUE IN OR AROUND THE SORE IS BLACK IF IT HAS DIED. THIS LEVEL REQUIRES TREATMENT BY A MEDICAL PROFESSIONAL TO REMOVE ANY DEAD TISSUE AND TO PRESCRIBE ANTIBIOTICS, IF INFECTED. THIS STAGE REQUIRES ONGOING MEDICAL INTERVENTION FOR 1-4 MONTHS TO HEAL. STAGE 4: THESE SORES ARE THE MOST SERIOUS. SOME MAY EVEN AFFECT MUSCLES AND LIGAMENTS. THE SORE IS DEEP AND BIG. SKIN HAS TURNED BLACK AND SHOWS SIGNS OF INFECTION -- RED EDGES, PUS, ODOR, HEAT, AND/OR DRAINAGE. YOU MAY BE ABLE TO SEE TENDONS, MUSCLES, AND BONE. THESE WOUNDS REQUIRE MEDICAL INTERVENTION (UP TO AND INCLUDING SURGERY) TO REPAIR THE DAMAGE. THIS STAGE REQUIRES ONGOING MEDICAL INTERVENTION FOR 4-12 MONTHS TO HEAL. MANY FACTORS CAN CONTRIBUTE TO SKIN BREAKDOWN IN PERSONS CONFINED TO A WHEELCHAIR FOR MOST WAKING HOURS. THESE FACTORS INCLUDE, LENGTH OF TIME SPENT IN A SEATED POSITION, MAKE-UP OF MATERIALS UPON WHICH END USER IS SEATED, PRESSURE RELIEF ACTIVITIES, REPOSITIONING ACTIVITIES, SENSATION, CIRCULATION, ETC. SINCE THE SEAT CUSHION ONLY MAKES UP ONE PORTION OF THE FACTORS THAT MAY CONTRIBUTE TO SKIN BREAKDOWN, THERE IS A STRONG BELIEF THAT THE USER MUST CONTRIBUTE TO THEIR OWN HEALTH THROUGH REGULAR INTERVALS OF PRESSURE RELIEF AND REPOSITIONING. THE MOST COMFORTABLE WHEELCHAIR CUSHION IN THE WORLD WILL NOT PREVENT SKIN BREAKDOWN IN AN END USER THAT DOES NOT PERFORM THEIR ACTIVITIES TO RELIEVE PRESSURE. THEREFORE, THERE IS NO EXPECTATION THAT A SEATING CUSHION HAS MALFUNCTIONED IF SKIN BREAKDOWN OCCURS. SUNRISE MEDICAL, AS A PRACTICE, REPORTS ALL PRESSURE SORES THAT BREAK THROUGH THE SKIN (STAGE 2 AND ABOVE) AS A "SERIOUS INJURY" BECAUSE THIS LEVEL OF INJURY REQUIRES INTERVENTION TO ENSURE THEY DO NOT PROGRESS. DISCUSSION: THE CUSHION AT THE TIME OF THE COMPLAINT WAS 9 MONTHS OF AGE. THE LIFETIME OF A WHEELCHAIR CUSHION IS 2 YEARS. THEREFORE, THIS CUSHION HAD NOT YET REACHED ITS EFFECTIVE LIFETIME. THE PRESENCE OF AIR IN THE FLUID PAD IS CONSIDERED A MALFUNCTION AND IS LIKELY DUE TO MANUFACTURING OR ASSEMBLY PROCESSES. IT IS UNLIKELY THAT USE WOULD HAVE INTRODUCED AIR INTO THE FLUID PAD. CONCLUSION: DUE TO THE MALFUNCTION OF THE CUSHION AND A MINOR INJURY, WITH THE POTENTIAL FOR DEVELOPING INTO A SERIOUS INJURY, AN MDR IS BEING FILED. ADDITIONAL INFORMATION: THIS COMPLAINT HAS BEEN RE-REVIEWED AS A PART OF A FOUR-YEAR RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING AND ADVERSE EVENT REPORTING PROCESSES. A LEGAL CONSULTING FIRM WAS CONSULTED FOR THE RETROSPECTIVE REVIEW. THIS MDR IS BEING FILED BASED ON THE OUTCOME OF THAT RETROSPECTIVE REVIEW.

Description of Event or Problem · 1

DEALER STATES THAT THE FLUID PAD COVER IS SPLITTING. DEALER STATES THAT END USER HAS HAD SOME SKIN BREAKDOWN. NO INFORMATION ON WHERE THE SKIN BREAKDOWN IS HAPPENING. DEALER DOES NOT KNOW IF ANY MEDICAL TREATMENT HAS BEEN SOUGHT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1216832	JAY FLUID PAD	WHEELCHAIR CUSHION	KNN	SUNRISE MEDICAL (US) LLC	JAY

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Other