BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2641463 · Received July 6, 2012

    Report

    Report Number
    1531186-2012-00477
    Date Received
    July 6, 2012
    Report Date
    July 5, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9781 SERIAL NUMBER/DATE CODE (B)(4) (INVALID NUMBER PROVIDED). THE OWNER'S MANUAL PART NUMBER 1122173 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER IS A (B)(6) FEMALE, (B)(6). THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CONSUMER CALLED STATING THAT THE LEGS ON THE 9781 SHOWER CHAIR SHE RECEIVED FROM THE HOSPITAL IS ALLEGEDLY UNSTABLE. PAGE 1 OF THE INSTRUCTION SHEET STATES THE FOLLOWING WARNINGS, "ALL FOUR LEG TIPS MUST BE IN CONTACT WITH SHOWER/TUB FLOOR AT ALL TIMES. ALWAYS INSPECT THE SHOWER CHAIR TO ENSURE THAT IT IS PROPERLY POSITIONED AND STABLE BEFORE USING. DO NOT USE THE SHOWER CHAIR IF IT IS WOBBLY OR UNSTABLE. THE SHOWER CHAIR LEGS HAVE SUCTION FEET. CHECK THE SUCTION FEET FOR RIPS, TEARS, CRACKS OR WEAR. IF ANY OF THESE CONDITIONS EXIST, REPLACE THEM IMMEDIATELY. THIS PRODUCT SHOULD ONLY BE USED WITH TUB FLOORS WIDER THAN 16-INCHES. USERS WITH LIMITED PHYSICAL CAPABILITIES SHOULD BE SUPERVISED OR ASSISTED WHEN USING THE SHOWER CHAIR". NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE CHAIR LEGS ARE VERY UNSTABLE. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 9781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other