BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTATION CUSHION

    MDR report key: 2261275 · Received September 23, 2011

    Report

    Report Number
    9615350-2011-00001
    Event Type
    Malfunction
    Date Received
    September 23, 2011
    Date of Event
    August 30, 2011
    Report Date
    August 30, 2011
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    KIC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS CUSHION. MODEL ITFM 20X80 SERIAL NUMBER UNKNOWN. USER MANUAL PART NUMBER 1141447 REV B (B)(4) WAS ISSUED FOR THE CONSUMERS OF THIS DEVICE. IT IS UNKNOWN OF THE USER HAS FULLY READ AND UNDERSTANDS THE USERS MANUAL. ON PAGE 1 THE FOLLOWING WARNING IS PROVIDED: "WARNING - DO NOT USE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THESE INSTRUCTIONS. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS, AND INSTRUCTIONS, CONTACT DISTRIBUTOR BEFORE ATTEMPTING TO USE THIS EQUIPMENT, OTHERWISE, INJURY OR DAMAGE MAY RESULT. CHECK ALL PARTS FOR SHIPPING DAMAGE AND TEST BEFORE USE. IN CASE OF DAMAGE, DO NOT USE. CONTACT THE DISTRIBUTOR FOR FURTHER INSTRUCTIONS." THE MEDICAL CONDITION, STABILITY OR MEDICATION REGIMEN OF THE CONSUMER IS UNKNOWN. THE CONSUMERS WEIGHT IS (B)(6) WHICH MEET THE WEIGHT LIMITATIONS, THE FOLLOWING WARNINGS ARE PROVIDED: "THE FLOVAIR CUSHION IS NOT DESIGNED FOR USE IN THE TREATMENT OF PRESSURE SORES." "SKIN CONDITION SHOULD BE CHECKED VERY FREQUENTLY AFTER THE INSTALLATION OF ANY NEW CUSHION." "YOUR THERAPIST AND PHYSICIAN SHOULD BE CONSULTED IF YOU HAVE ANY QUESTIONS REGARDING WEIGHT RELIEF, SELF-EXAMINATION OF THE SKIN, OR INDIVIDUAL LIMITATIONS AND NEEDS." "MAKE SURE THE HOOK AND LOOP FASTENING STRAPS ARE SECURELY ATTACHED BETWEEN THE SEATING SURFACE AND CUSHION BEFORE USING." "THE FLOVAIR CUSHION HAS A WEIGHT LIMITATION OF 250 LBS FOR CUSHION WIDTHS UP TO AND INCLUDING 20 AND 350 LBS FOR CUSHION WIDTHS OVER 20. IT IS UNKNOWN IF THE CORRECT CUSHION WAS CHOSEN FOR THIS CONSUMER. ON PAGE 2 THE FOLLOWING WARNING IS PROVIDED: "ALL CUSHIONS SHOULD BE SELECTED CAREFULLY. WORKING WITH YOUR THERAPIST, AND PHYSICIAN IS THE BEST WAY TO ASSURE THAT A CUSHION CHOICE MATCHES YOUR INDIVIDUAL NEEDS. AS THE NEEDS OF THE INDIVIDUAL BECOME MORE COMPLEX, CUSHION EVALUATION BECOMES MORE IMPORTANT." THE CONDITION OF THE CUSHION IS UNKNOWN: ON PAGE 2 THE FOLLOWING WARNING IS PROVIDED: "WARNING - DO NOT CONTINUE TO USE THIS PRODUCT IF ANY OF THE UPHOLSTERY MATERIALS, FOAMS, AND/OR PLASTICS ARE FOUND TO BE DEFORMED, BREAKING, WORN, AND/OR COMPRESSED. CORRECTIVE MAINTENANCE CAN BE PERFORMED AT OR ARRANGED THROUGH YOUR EQUIPMENT SUPPLIER." IT IS UNKNOWN IF THE CONSUMER OR ASSISTANT VERIFIED THAT THE HOOK AND LOOP FASTENERS WERE SECURE. ON PAGE 2 THE FOLLOWING WARNING IS PROVIDED: "MAKE SURE THE HOOK AND LOOP FASTENERS ARE SECURELY ATTACHED TO THE SEATING SURFACE AND TO THE CUSHION BEFORE USING. IF THE CUSHION IS NOT SECURED TO THE SEATING SURFACE, USE CAUTION WHEN TRANSFERRING IN AND OUT OF THE WHEELCHAIR." IT IS UNKNOWN WHICH FEATURES ARE IN USE ON THIS CUSHION, IT IS UNKNOWN IF THE CONSUMER FOLLOWS THE INSTRUCTIONS FOR DEALING WITH THE FEATURES OF THE CUSHION. THE INSTRUCTIONS ARE LISTED BELOW,: PAGE 3 HOOK ATTACHMENT STRIPS/NO ATTACHMENT STRIPS, PAGE 3 LOOP ATTACHMENT STRIPS, PAGE 4 REMOVING/INSTALLING THE CUSHION COVERS, PAGE 6 INSTALLING THE PELVIC SUPPORT LAYER, PAGE 7 REMOVING/INSTALLING REMOVABLE LEG WEDGES.

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 9615350-2011-00001 INDICTING THE MANUFACTURER AS MOTION CONCEPTS AND THE FDA REGISTRATION NUMBER AS (B)(4). THE CORRECT MANUFACTURER IS INVACARE TAYLOR STREET AND THE FDA REGISTRATION NUMBER IS (B)(4).

    Description of Event or Problem · 1

    WHILE THE CONSUMER WAS BEING PUT IN HER CHAIR, THE CUSHION ALLEGEDLY SLID OFF, CAUSING HER TO FALL. NO INJURY IS ALLEGED. THE MODEL OF THE WHEELCHAIR IS NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTATION CUSHION 890.3175 KIC INVACARE TAYLOR STREET ITFM 20X18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other