BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR ACCESSORY

    MDR report key: 2287816 · Received October 12, 2011

    Report

    Report Number
    3003433498-2011-00015
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Date of Event
    September 13, 2011
    Report Date
    October 10, 2011
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    KNO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS DEVICE. CARROLL HEALTHCARE [INVACARE CONTINUING CARE] BED, MODEL CS FX600, HAS AN ACCESSORY TRAPEZE BAR MODEL IHCSTRPHD SERIAL NUMBER UNKNOWN, WAS IN USE AT THE TIME OF THE CONSUMER WAS HIT IN THE HEAD. THE AGE AND HEIGHT OF THE CONSUMER IS UNKNOWN. INVACARE PROVIDES A USER INSTALLATION INSTRUCTIONS PART NUMBER (B)(4) TRAPEZE INSTALLATION ON CS BED.DOC CARROLL HEALTHCARE INC. THE CONSUMER WEIGHS (B)(6) LBS. THE AMOUNT OF WEIGHT/FORCE THE CONSUMER USED TO REPOSITION IS UNKNOWN. ON PAGES 2 AND 3 OF THE INSTALLATION INSTRUCTIONS THE FOLLOWING WARNINGS ARE PROVIDED: "SAFE WORKING LOAD OF THE STANDARD TRAPEZE IS 168 LB. (750 N). DO NOT EXCEED 168 LB. (750 N)." "SAFE WORKING LOAD OF HEAVY DUTY TRAPEZE IS 250 LBS. (1115 N). DO NOT EXCEED 250 LB. (1115 N)."

    Description of Event or Problem · 1

    THE CONSUMER TRIED TO REPOSITION HIMSELF IN BED WITH THE TRAPEZE HANDLE, WHEN THE HANDLE ALLEGEDLY PULLED AWAY FROM THE BAR AND HIT HIM IN THE FACE. NO INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR ACCESSORY 890.3910 KNO CARROLL HEALTHCARE IHCSTRPHD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other