BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE S646

    MDR report key: 12321429 · Received August 13, 2021

    Report

    Report Number
    2937137-2021-00040
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    August 12, 2020
    Report Date
    August 13, 2021
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    UDI-DI
    00016958044256
    PMA / PMN Number
    K010917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BACKGROUND INFORMATION: SUNRISE MEDICAL POWER WHEELCHAIRS ARE DESIGNED TO SAFELY ASCEND AND DESCEND 10% SLOPES WHILE REMAINING STABLE. IT IS UNKNOWN WHAT ANGLE SLOPE THE USER WAS ATTEMPTING TO ASCEND; SIMPLY REFERRED TO AS A "STEEP INCLINE." QUICKIE S626/636/646 OWNER MANUAL (P/N 930570, REV C, SECTION S, PAGE 18 STATES: "S. RAMPS, SLOPES & SIDEHILLS - WARNING! - THE CENTER OF BALANCE OF YOUR CHAIR CHANGES WHEN YOU ARE ON A SLOPE. NOTE- "SLOPE" INCLUDES A RAMP OR SIDE HILL. YOUR CHAIR IS LESS STABLE WHEN IT IS AT AN ANGLE. NEVER USE THIS CHAIR ON A SLOPE UNLESS YOU ARE SURE IT IS SAFE. WHEN IN DOUBT, HAVE SOMEONE HELP YOU. BEWARE OF: 1. STEEP SLOPES. DO NOT USE THIS CHAIR ON A SLOPE STEEPER THAN 10%. (A 10% SLOPE MEANS: ONE FOOT IN ELEVATION FOR EVERY TEN FEET OF SLOPE LENGTH). PAGE 19 OF THE OWNER MANUAL STATES: "T. TO REDUCE THE RISK OF A FALL, TIP-OVER OR LOSS OF CONTROL: 1. NEVER USE YOUR CHAIR ON A SLOPE UNLESS YOU ARE SURE YOU CAN DO SO WITHOUT LOSING TRACTION. 2. ALWAYS GO AS STRAIGHT UP AND AS STRAIGHT DOWN AS YOU CAN. · DO NOT "CUT THE CORNER" ON A SLOPE OR RAMP. · DO NOT TURN OR CHANGE DIRECTION ON A SLOPE. 3. ALWAYS STAY IN THE CENTER OF THE RAMP. MAKE SURE RAMP IS WIDE ENOUGH THAT YOU ARE NOT AT RISK THAT A WHEEL MAY ROLL OFF THE SIDE. 4. LEAN OR PRESS YOUR BODY UPHILL. THIS WILL HELP ADJUST FOR A CHANGE IN THE CENTER OF BALANCE CAUSED BY THE SLOPE. (FIG. 1) 5. KEEP YOUR CHAIR MOVING AT A SLOW, STEADY SPEED. KEEP CONTROL OVER THE CHAIR AT ALL TIMES. · ON A DESCENT, DO NOT LET YOUR CHAIR ACCELERATE BEYOND ITS NORMAL SPEED. · IF THE CHAIR PICKS UP SPEED, CENTER THE JOYSTICK TO SLOW DOWN OR STOP." DISCUSSION: THE COMPLAINANT DOES NOT STATE WHAT SLOPE THE INCLINE WAS AT, BUT THE PRODUCT IS DEVELOPED TO OPERATE SAFELY ON ANY INCLINE (FOLLOWING SAFE OPERATING INSTRUCTIONS) ON A SLOPE OF UP TO 10%. ATTEMPTING TO CLIMB OR DESCEND A SLOPE GREATER THAN 10% CAN CAUSE TIPOVER. THIS IS AN INHERENT RISK IN WHEELCHAIRS AS THEY HAVE A POINT OF INSTABILITY IF THEY ARE PUSHED BEYOND THEIR SAFE OPERATING LIMITS. THIS MODEL WHEELCHAIR IS EQUIPPED WITH A TILT ACTUATOR THAT SENDS A SIGNAL TO THE ANTI-TIP ACTUATOR. IN THIS CASE, THE CAUSE OF FAILURE COULD BE A MALFUNCTION OF THE TILT ACTUATOR OR THE HARNESS THAT CONNECTS WITH THE ANTI-TIP ACTUATOR. THIS MALFUNCTION MAY HAVE ALLOWED MORE FLEX THAN WOULD HAVE HAPPENED OTHERWISE ON THE ANTI-TIPS THAT MAY HAVE CONTRIBUTED TO THE FALL. CONCLUSION: MOST LIKELY ROOT CAUSE IS AN ANTI-TIP ACTUATOR FAILURE TO ACTIVATE BASED ON THE OPEN CIRCUIT FOUND ON THE ANTI-TIP ACTUATOR. THIS MALFUNCTION MOST LIKELY CONTRIBUTED TO THE TIP-OVER RESULTING IN A MINOR INJURY. TIP-OVERS IN POWER WHEELCHAIRS ARE CONSIDERED POTENTIAL FOR SERIOUS INJURY IF THEY ARE TO RECUR. THEREFORE, AN MDR IS BEING FILED FOR THIS INCIDENT. ADDITIONAL INFORMATION: THIS COMPLAINT HAS BEEN RE-REVIEWED AS A PART OF A FOUR-YEAR RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING AND ADVERSE EVENT REPORTING PROCESSES. A LEGAL CONSULTING FIRM WAS CONSULTED FOR THE RETROSPECTIVE REVIEW. THIS MDR IS BEING FILED BASED ON THE OUTCOME OF THAT RETROSPECTIVE REVIEW.

    Description of Event or Problem · 0

    DEALER CALLED IN TO STATE THAT END USER WAS GOING UP STEEP INCLINE ON APPROXIMATELY (B)(6) 2020 WHEN CHAIR TIPPED OVER BACKWARDS RESULTING IN A BRUISED ARM (SIZE OF A GOLF BALL). DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215038 QUICKIE S646 REAR WHEEL DRIVE POWER WHEELCHAIR ITI SUNRISE MEDICAL (US) LLC S646 00016958044256

    Patients

    Seq Age Sex Outcome Treatment
    1 Other