BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAY FUSHION CRYO

    MDR report key: 12381239 · Received August 28, 2021

    Report

    Report Number
    9616084-2021-00054
    Event Type
    Injury
    Date Received
    August 28, 2021
    Date of Event
    June 29, 2021
    Report Date
    August 28, 2021
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    KNN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BACKGROUND INFORMATION: JAY FUSION CRYO OWNER MANUAL (P/N 121985, REV F, PAGE 9) PROVIDES MAINTENANCE INSTRUCTIONS THAT INCLUDE MONTHLY (OR MORE OFTEN) KNEADING TO RETURN FLUID TO ORIGINAL CONSISTENCY AND TO PREVENT BOTTOMING OUT. THE AGE OF THE CUSHION AT THE TIME OF THE COMPLAINT IS 8 MONTHS. DISCUSSION: THE FLUID CUSHIONS MAY DEVELOP HARD SPOTS IF NOT PROPERLY MAINTAINED OVER THEIR LIFETIME. THEREFORE, IT IS LIKELY THAT THE END USER DID NOT PERFORM PROPER MONTHLY MAINTENANCE ON THEIR JAY FUSION CRYO WHEELCHAIR CUSHION AND IT DEVELOPED A HARD SPOT WHICH IS A KNOWN ISSUE WITH THESE CUSHIONS. WHILE THIS IS A KNOWN ISSUE WITH THESE CUSHION DESIGNS, THE BENEFITS OF PROVIDING A FLUID-FILLED WHEELCHAIR CUSHION FOR PERSONS PRONE TO PRESSURE SORES DUE TO PREEXISTING CONDITIONS GREATLY OUTWEIGHS THE RISK OF DEVELOPING PRESSURE SORES. PROPER PRESSURE SORE PREVENTION (AS DESCRIBED BY 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) REQUIRES MULTIPLE FACTORS THAT 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 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. CONCLUSION: THERE IS NO MALFUNCTION OF THE CUSHION IN QUESTION; THE CUSHION PERFORMED AS INTENDED. THE REPORTED ISSUE IS MOST LIKELY DUE TO USER FAILING TO PERFORM MONTHLY MAINTENANCE TO ENSURE CONSISTENCY OF FLUID IN THEIR WHEELCHAIR CUSHION WHICH RESULTED IN A "HARD" SPOT IN THE GEL CUSHION. THIS HARDENING MAY HAVE CONTRIBUTED TO A NEGLIGIBLE (STAGE 1) PRESSURE SORE WHICH IS DESCRIBED AS SKIN DISCOLORATION WITHOUT BROKEN SKIN. PRESSURE SORES IF LEFT UNTREATED MAY LEAD TO MORE SERIOUS INJURIES AND, ALTHOUGH THERE IS NO SERIOUS INJURY IN THIS CASE, THIS INCIDENT IS BEING REPORTED AS THE POTENTIAL FOR SERIOUS INJURY IF THE REPORTED ISSUE WERE TO RECUR.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE DEALER STATED THAT THEIR RESIDENT ASSISTIVE TECHNOLOGY PROFESSIONAL (ATP) WENT TO VISIT THE PATIENT AND THE PATIENT COMPLAINED THAT THE "GEL PAD WAS ROCK HARD" AND WAS DEVELOPING A PRESSURE SORE. GEL CUSHION PHOTOS WERE PROVIDED AND NO OBVIOUS MALFUNCTIONS COULD BE SEEN. NO DESCRIPTION BY ATP PROVIDED REGARDING CLAIM OF GEL CUSHION HARDNESS (HARDNESS CANNOT BE DETERMINED BY PHOTOGRAPH ALONE). ATP EXAMINED END USER DURING VISIT ON (B)(6)2021 AND STATED THAT HE HAS A RED, IRRITATED SKIN (NO DESCRIPTION OF LOCATION), BUT STATES THAT IT IS NOT AN OPEN WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278452 JAY FUSHION CRYO WHEELCHAIR CUSHION KNN SUNRISE MEDICAL (US) LLC JAY FUSION CRYO

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR