BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 2515793 · Received April 4, 2012

    Report

    Report Number
    1531186-2012-00107
    Date Received
    April 4, 2012
    Date of Event
    March 5, 2012
    Report Date
    April 3, 2012
    Manufacturer
    UNKNOWN
    Product Code
    INN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER IS A (B)(6) MALE. THE 9780 IVC-I FIT SHOWER CHAIR HAS A WEIGHT LIMITATION OF 400 POUNDS. THE DEALER STATED THAT THE CONSUMER INSTALLED THE LEGS ON THE SHOWER CHAIR, OUT OF BOX AND THE LEGS ALLEGEDLY COLLAPSED WHEN HE WENT TO TRANSFER ONTO THE BENCH. THE OWNER'S MANUAL PART NUMBER 1122173 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. THE OWNER'S MANUAL INSTRUCTS FOR INSTALLING THE LEGS, "PUSH THE LEG DOWN INTO THE SOCKET UNTIL IT IS FULLY SEATED AND THE LOCKING TABS ARE THROUGH THE SOCKET TAB WINDOWS. PULL UP ON THE LEG TO ENSURE THAT IT HAS "LOCKED" INTO PLACE". 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 OWNER'S MANUAL COMES WITH THE WARNINGS, "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. THE SHOWER CHAIR IS NOT TO BE USED AS A TRANSFER BENCH, TRANSFER DEVICE OR CLIMBING DEVICE. AFTER ANY ADJUSTMENTS, REPAIR OR SERVICE AND BEFORE USE, MAKE SURE THAT ALL PARTS ARE PROPERLY INSTALLED AND SECURE".

    Description of Event or Problem · 1

    DEALER STATED THAT THE LEGS ON SHOWER CHAIR ALLEGEDLY COLLAPSED ON THE CONSUMER. (B)(4). NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES 890.5050 INN UNKNOWN 9780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other