BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE QXI

    MDR report key: 6807450 · Received August 21, 2017

    Report

    Report Number
    9616084-2017-00005
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    July 22, 2017
    Report Date
    January 23, 2018
    Manufacturer
    SUNRISE MEDICAL PRIVADA MISIONES
    Product Code
    IOR
    PMA / PMN Number
    K072153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED BY SUNRISE MEDICAL'S LEAD ENGINEER. THE FOLLOWING INCLUDES ALL SUPPORTING DATA USED TO DETERMINE THE PROBABLE CAUSE OF FAILURE. THE MOST PROBABLE CAUSE OF THE FAILURE STEMMED FROM THE OVER TIGHTENING OF THE BACKREST UPHOLSTERY. OVERTIGHTENING THE BACKREST UPHOLSTERY ON A FOLDING WHEELCHAIR CAUSES EXCESSIVE BENDING AND SHEER LOADS ON THE CROSS BRACE CENTER PIVOT DURING THE FOLDING PROCESS. AS A RESULT THE INITIAL COMPONENT FAILURE POINT IS MOST LIKELY THE CROSS BRACE CENTER PIVOT. BASED ON THE OBSERVATIONS MADE DURING THIS INVESTIGATION THE MOST LIKELY SEQUENCE OF EVENTS THAT OCCURRED DURING THE COMPLAINT LISTED BELOW IS AS FOLLOWS: CROSS BRACE CENTER PIVOT BROKE. THIS MAY HAVE OCCURRED PRIOR TO THE INCIDENT OR AS A RESULT OF THE INITIAL LOADING AS THE CHAIR WAS MANEUVERED UP THE SIDEWALK CUTOUT. WHEN THE END USER PERFORMED THE MANEUVER MENTIONED IN THE COMPLAINT, THE CROSS BRACE SHIFTED. THIS CAUSED THE END USER'S WEIGHT TO SHIFT REARWARD AND TO THE LEFT. THIS SHIFT IN MASS RESULTED IN AN EXCESSIVE LOAD BEING APPLIED TO THE REAR LEFT ANTI-TIP AS A RESULT OF THIS LOADING THE BASE MATERIAL OF THE REAR SIDE FRAME BEGAN TO TEAR CAUSING THE ANTI-TIP TO PIVOT INWARD. AS THE ANTI-TIP CONTINUED TO BE LOADED WHILE ROTATING INWARD THE SIDE LOAD ON THE ANTI-TIP RECEIVER EXCEEDED THE MATERIAL STRENGTH AND THE RECEIVER FRACTURED. IT IS REASONABLE TO ASSUME THAT THE EVENTS AND COMPONENT FAILURES OCCURRED IN THIS ORDER BECAUSE: THE CROSS BRACE PIVOT FAILED FIRST: A SIGNIFICANT LOAD ON THE ANTI-TIP WOULD BE REQUIRED IN ORDER TO CAUSE THE REAR SIDE FRAME TO TEAR. TESTING TO SUNRISE MEDICAL TEST PROTOCOL (B)(4) HAS SHOWN THAT THIS MODE OF FAILURE WOULD NOT BE SEEN UNDER NORMAL STATIC OR DYNAMIC LOADING OF THE ANTI-TIP. THIS TYPE OF EXCESSIVE LOADING IS INDICATIVE OF A WEIGHT SHIFT CAUSED BY A CHANGE TO THE CHAIR'S STRUCTURAL INTEGRITY. A BROKEN CROSS BRACE PIVOT WOULD CONSTITUTE A CHANGE TO THE CHAIR'S STRUCTURAL INTEGRITY. THE REAR SIDE FRAME FAILED SECOND: AFTER THE ANTI-TIP RECEIVER FAILS THE MEANS FOR APPLYING LOAD TO THE SIDE FRAME HAD BEEN REMOVED. THEREFORE, THE FRAME FRACTURE MUST HAVE OCCURRED PRIOR TO THE ANTI-TIP RECEIVER FRACTURE. ALSO, THE SIDE FRAME WOULD HAVE BEEN PROTECTED BY THE REAR WHEEL DURING THE FALL SO IMPACT DAMAGE CAN BE RULED OUT. THE REAR ANTI-TIP RECEIVER FAILED LAST: ONCE THE ANTI-TIP RECEIVER FAILED ALL LOADING WAS REMOVED FROM THE SYSTEM. ONCE THE REAR SIDE FRAME BEGAN TO FAIL THE MATERIAL'S STRUCTURAL INTEGRITY WAS COMPROMISED. THE ANTI-TIP WOULD HAVE CONTINUED TO ROTATE UNDER THE CHAIR AND THE FALL WOULD HAVE OCCURRED WITH OR WITHOUT THE FAILURE OF THE ANTI-TIP RECEIVER.

    Additional Manufacturer Narrative · 1

    SUNRISE MEDICAL HAS REQUESTED FROM THE DEALER THE RETURN OF THE DAMAGED PARTS FOR A FULL EVALUATION. IT IS NOT CLEAR IF THE ANTI-TIP RECEIVER, CROSS BRACE AND LEFT SIDE FRAME BROKE CAUSING THE FALL OR IF THESE PARTS BROKE AS A RESULT OF THE FALL. IT CANNOT BE DETERMINED AT THIS TIME IF A MALFUNCTION OCCURRED OR IF ANY OF THE PARTS ARE DEFECTIVE, AS IT IS ONLY SPECULATION ON THE DEALERS PART IN STATING THAT THE ANTI-TIP RECEIVER BROKE, CAUSING THE CHAIR TO FALL; WHERE THE CHAIR COULD HAVE FALLEN TO THE SIDE DUE TO IT ROLLING BACKWARD OFF THE CURB WHILE THE END USER WAS ATTEMPTING TO RE-GRIP THE WHEELS, CAUSING THE PARTS TO THEN BREAK. NEW REPLACEMENT PARTS WERE SHIPPED TO THE DEALER ON 7/28/17 FOR REPAIRS. UPON RECEIVING THE DAMAGED PARTS, A FULL EVALUATION WILL BE PERFORMED AND A FOLLOW UP REPORT WILL BE SUBMITTED WITH OUR FINDINGS.

    Description of Event or Problem · 1

    PLEASE SEE INITIAL MDR 9616084-2017-00005.

    Description of Event or Problem · 1

    DEALER (B)(6) STATES END USER LIVES IN A GROUP HOME AND WAS TRANSPORTED VIA BUS TO A SHOPPING MALL AND WAS USING THE SIDE WALK CUT OUT AND STARTED UP AND ROLLED BACK. HE RE-GRIPPED TO GO UP IT AGAIN AND THE LEFT ANTI-TIP RECEIVER BROKE. PER (B)(6) THERE WAS ONE BRUISE ON CLIENTS LEFT FORM ARM. DEALER ALSO STATED WHEN THE ANTI-TIP RECEIVER BROKE THE CHAIR FELL TO THE LEFT AND THE CLIENT CAME OUT OF THE CHAIR. UPON INSPECTION (B)(6) FOUND THE THREADED BARREL OF CROSS BRACE SNAPPED AND LEFT SIDE FRAME WAS ALSO BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586733 QUICKIE QXI MANUAL WHEELCHAIR IOR SUNRISE MEDICAL PRIVADA MISIONES EIF6

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR