BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAY FLOLITE PAD

    MDR report key: 12322214 · Received August 14, 2021

    Report

    Report Number
    9616084-2021-00050
    Event Type
    Malfunction
    Date Received
    August 14, 2021
    Date of Event
    January 14, 2021
    Report Date
    August 14, 2021
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    KNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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. SUNRISE PRODUCTS THAT ARE ORDERED WITH CUSHIONS, ARE PROVIDED CUSHIONS PER DEALER/PROVIDER SPECIFICATIONS. THERE ARE NUMEROUS CUSHION CONFIGURATIONS; SOME ARE DESIGNED FOR INDIVIDUALS MORE PRONE TO DEVELOPING PRESSURE SORES AND SOME ARE NOT. THE DETERMINATION OF WHETHER OR WHICH CUSHION IS NEEDED IS THE DEALER/PROVIDER RESPONSIBILITY TO SPECIFY AS SOME USERS MAY BE DETERMINED, BY A MOBILITY SPECIALIST, TO NEED SPECIFIC CUSHION TYPES (FLUID, GEL, FOAM, ETC.). THIS REQUIREMENT CANNOT BE DETERMINED BY SUNRISE MEDICAL AS WE DO NOT KNOW THE CONDITION OF THE END USER, NOR THE SPECIFIC NEEDS OF THEIR DISABILITY. WHEN SPECIFIC CUSHIONS ARE PROVIDED, PER DEALER REQUIREMENTS, THE EXPECTATION IS THE CUSHION WILL BE FREE OF MANUFACTURING DEFECTS AND WILL PERFORM IN ACCORDANCE WITH ALL WRITTEN MATERIALS (WEBSITE, OWNER MANUAL, ETC.). WHEN CUSHIONS DO NOT PERFORM AS INTENDED, IT IS CONSIDERED A MALFUNCTION OF THE DEVICE AND PRESSURE SORES, WHETHER A SERIOUS INJURY OR NOT, HAVE THE POTENTIAL FOR BECOMING A SERIOUS INJURY. THEREFORE, MOST MALFUNCTIONS OF WHEELCHAIR CUSHIONS ARE CONSIDERED REPORTABLE EVENTS. DISCUSSION: THE CUSHION AT THE TIME OF THE COMPLAINT WAS 1 MONTH 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 OF MANUFACTURING OR ASSEMBLY. CONCLUSION: DUE TO THE MALFUNCTION OF THE CUSHION AND THE REPORT OF AN INJURY, WITHOUT DEFINITION OF SEVERITY. HOWEVER, DUE TO THE FACT THAT PRESSURE SORES CAN PROGRESS TO SERIOUS INJURIES OR COULD RESULT IN SERIOUS INJURIES IF THE MALFUNCTION WERE TO RECUR, 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 STATED THERE SEEMS TO BE AIR INSIDE THE CLIENTS FLOLITE PAD MAKING THINGS UNCOMFORTABLE FOR HIM. STATED THAT THE CLIENT RECEIVED A SACRAL PRESSURE WOUND AND HIS MEDICAL CLINIC IS TREATING IT LOCALLY (NO HOSPITALIZATION NEEDED). UNSURE WHAT SEVERITY OF PRESSURE WOUND DEVELOPED. IN ABSENCE OF FURTHER INFORMATION, WILL FILE MDR AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219480 JAY FLOLITE PAD WHEELCHAIR CUSHION KNN SUNRISE MEDICAL (US) LLC JAY FLOLITE PAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention