BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE IRIS

    MDR report key: 2243958 · Received September 6, 2011

    Report

    Report Number
    MW5022157
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 6, 2011
    Manufacturer
    SUNRISE MEDICAL (US)
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE JAY J3 BACK ACCIDENTLY DISCONNECTED FROM THE QUICKIE IRIS WHEELCHAIR, RESULTING IN AN INJURIOUS FALL. THE WHEELCHAIR RIDER WAS SEATED IN THE DINING HALL OF A NURSING HOME, IN PREPARATION FOR BEING FED BY A NURSE. HE TURNED HIS HEAD, AND THEN THE BACKREST OF THE WHEELCHAIR FELL BACKWARDS ONTO THE GROUND, FOLLOWED BY THE PT AND THE WHEELCHAIR. THE PT WAS TRANSPORTED TO THE EMERGENCY DEPT AND DIAGNOSED WITH A NON-DISPLACED GREATER TUBEROSITY HUMERAL FRACTURE. THIS PARTICULAR WHEELCHAIR WAS MODIFIED TO HAVE THE J3 BACKREST MOUNTED BY A VENDOR. THERE ARE TWO MOUNTING BRACKETS, AND WITHIN EACH BRACKET A SMALL LEVER IS PUSHED FORWARD TO QUICK-RELEASE THE BACKREST AND PUSHED BACK TO SECURE IT IN PLACE. THERE ARE ALSO TWO SIX-INCH CABLES HOLDING A KEY RING/LOCKING PIN. WHEN THE LOCKING PINS ARE SECURE IT PREVENTS THE BACK FROM BEING RELEASED FROM THE CHAIR. IN THIS EVENT, THE LOCKING PINS WERE NOT INSERTED IN THE BRACKET. PRESUMABLY THE LEVER WAS IN THE FORWARD POSITION MAKING THE BACKREST UNSTABLE AND THE PT FELL BACKWARDS OUT OF THE CHAIR. PRODUCT VULNERABILITIES: THE QUICKIE IRIS HAS TWO SETS OF LOCKING PINS ON THE BACK OF THE WHEELCHAIR. ONE SET CAN BE LOCKED FOR POSITIONING; IT IS NORMAL FOR THIS SET TO BE LEFT UNLOCKED/HANGING. THE OTHER SET IS ASSOCIATED WITH THE BACKREST AND MUST BE ENGAGED TO PREVENT THE BACK FROM BEING RELEASED FROM THE CHAIR. BOTH SETS OF LOCKING PINS/CABLES ARE IDENTICAL IN APPEARANCE/FUNCTION, INCREASING LIKELIHOOD OF PRODUCT USE ERROR. RECOMMENDATIONS: WARNING LABELS AT POINT OF USE ON THE SIX-INCH CABLES FOR THE J3 BACK. LABELS SHOULD STATE "WARNING: PIN MUST BE INSERTED FOR SAFETY PRIOR TO SITTING IN WHEELCHAIR" OR SIMILAR LANGUAGE. LABELS SHOULD BE BRIGHTLY COLORED, WATERPROOF, MADE OF STRONG ADHESIVE, PERMANENTLY AFFIXED. RE-DESIGN LOCKING PIN FOR J3 BACK TO ALLOW USERS TO OPT OUT OF THE QUICK RELEASE FUNCTIONALITY. FOR EXAMPLE, ADD A NUT THAT WOULD NEED TO BE REMOVED WITH WRENCH BEFORE BEING ABLE TO REMOVE THE LOCKING PIN. HIGHLIGHT IMPORTANCE OF ASSURING J3 BACK LOCKING PINS ARE SECURED TO SEATING WITH NEW WARNING PLACED IN THE MFRS' INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKIE IRIS WHEELCHAIR IOR SUNRISE MEDICAL (US)
    2 JAY J3 BACK WHEELCHAIR BACKREST IOR SUNRISE MEDICAL (US)
    3 J3 BCK STD CLAMP HARDWARE CLAMP HARDWARE IOR SUNRISE MEDICAL (US)

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other