BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2193168 · Received August 5, 2011

    Report

    Report Number
    1525712-2011-00426
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    May 29, 2011
    Report Date
    August 5, 2011
    Manufacturer
    UNKNOWN
    Product Code
    IKX
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE "FRONT BAR" IS A METAL SUPPORT TUBE USED AS A CROSS BAR BETWEEN THE TWO FRONT LEGS OF THE COMMODE. THE FRONT SUPPORT TUBE SUPPORTS THE PAIL AND PROVIDES STABILITY FOR THE TWO FRONT LEGS. THE FRONT SUPPORT TUBE IS ATTACHED TO THE TWO FRONT LEGS BY BOLTS. IF ONE OF THE BOLTS WERE TO BACK OUT IT WOULD CAUSE THE "FRONT BAR TO FALL OUT OF THE HOLE". THE CONSUMER IS AN (B)(6) MALE WHO IS (B)(6) TALL AND WEIGHS (B)(6). THE CONSUMER HAS ALZHEIMER'S. IT IS NOT KNOWN IF THE CONSUMER HAS READ AND FULLY UNDERSTANDS THE INVACARE USER INSTRUCTIONS FOR THE COMMODE. BY FOLLOWING THE WARNINGS IN USER MANUAL PN (B)(4) PAGE 1 THE CONSUMER MAY HAVE PREVENTED THE EVENT: DO NOT USE THIS PRODUCT OR ANY AVAILABLE OPTIONAL EQUIPMENT WITHOUT FIRST COMPLETELY READING AND UNDERSTANDING THESE INSTRUCTIONS AND ANY ADDITIONAL INSTRUCTIONAL MATERIAL SUCH AS OWNER'S MANUALS, SERVICE MANUALS OR INSTRUCTION SHEETS SUPPLIED WITH THIS PRODUCT OR OPTIONAL EQUIPMENT. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS OR INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL BEFORE ATTEMPTING TO USE THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR. MAKE SURE THAT ALL ATTACHING HARDWARE, SCREWS, NUTS AND/OR BOLTS ARE TIGHT AT ALL TIMES. LEG EXTENSIONS WITH RUBBER TIPS MUST BE IN CONTACT WITH THE FLOOR AT ALL TIMES. INSPECT RUBBER TIPS ON THE LEG EXTENSIONS FOR RIPS, TEARS, CRACKS OR WEAR OR IF THEY ARE MISSING. REPLACE THEM IMMEDIATELY IF ANY OF THESE CONDITIONS EXIST. IF SO EQUIPPED, THE BACK TUBE WING NUTS MUST BE INSPECTED REGULARLY FOR TIGHTNESS - OTHERWISE INJURY OR DAMAGE MAY OCCUR.

    Description of Event or Problem · 1

    THE CONSUMER WENT TO SIT ON THE COMMODE WHEN THE FRONT BAR ALLEGEDLY FELL OUT OF THE HOLE AND THE CONSUMER FELL. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX UNKNOWN 9650-4

    Patients

    Seq Age Sex Outcome Treatment
    1 82