BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTATION CUSHION

    MDR report key: 2287337 · Received October 12, 2011

    Report

    Report Number
    9615350-2011-00002
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Date of Event
    September 14, 2011
    Report Date
    September 16, 2011
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    KIC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 9615350-2011-00002, INDICTING THE BRAND NAME AS AN ALTERNATING PRESSURE AIR FLOTATION MATTRESS, THE CORRECT NAME IS FLOTATION CUSHION; THE COMMON DEVICE NAME AS 880.5550, THE CORRECT DEVICE IS 890.3175; THE MANUFACTURER AS MOTION CONCEPTS WHEN THE MANUFACTURER IS INVACARE TAYLOR STREET. THE FDA REGISTRATION NUMBER WAS REPORTED AS (B)(4) WHEN IN FACT IT IS (B)(4) FOR INVACARE.

    Additional Manufacturer Narrative · 1

    (B)(4). HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. MODEL ITFM88 HAS AN UNKNOWN SERIAL NUMBER. THEREFORE, THE AGE OF THE DEVICE IS UNKNOWN. THE LATEST REVISION USER MANUAL FOR THIS DEVICE IS PART NUMBER (B)(4). IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 CONSUMER NOTIFIED INVACARE AFTER FINDING THE LEAK. 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." THE MAINTENANCE OF THE MATTRESS IS UNKNOWN. THE FOLLOWING CAUTION IS PROVIDED ON PAGE 2: "CAUTION - DO NOT USE FABRIC SOFTENERS OR BLEACH. DO NOT MACHINE DRY. AIR DRY ONLY. DO NOT DRY IN SUN." THE INSTALLATION TECHNIQUES OF THE MATTRESS ARE UNKNOWN. POOR TECHNIQUE MAY CAUSE ISSUES WITH THE GEL SACK. THE FOLLOWING WARNINGS AND CAUTIONS ARE PROVIDED: "WARNING - THE COVERS ARE DESIGNED TO PROTECT THE FOAM FROM MOISTURE AND TO PROVIDE FIRE RETARDENCY. DO NOT USE THE CUSHION WITHOUT EITHER THE INNER OR OUTER COVER. IF THE COVERS ARE TORN, THEY MUST BE REPLACED IMMEDIATELY." "CAUTION - DO NOT REMOVE BOTH THE OUTER COVER AND INNER COVER AT THE SAME TIME, OTHERWISE DAMAGE TO THE INNER COVER MATERIAL MAY OCCUR." "CAUTION - USE CARE NOT TO SNAG THE INNER COVER IN THE OUTER COVER ZIPPER, OR DAMAGE TO THE INNER COVER WILL OCCUR."

    Description of Event or Problem · 1

    THE GEL SACK ALLEGEDLY PUNCTURED AND LEAKED ON THE CONSUMERS SKIN AND CLOTHES BEFORE GOING ONTO THE FLOOR. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTATION CUSHION 890.3175 KIC INVACARE TAYLOR STREET ITFM 88

    Patients

    Seq Age Sex Outcome Treatment
    1 Other