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Background information: quickie 2 owner manual, mk-100070, rev f, page 6: "i.Environmental conditions - warning: (2a) do not use your chair in a shower, pool or other body of water.The chair tubing and parts are not water-tight and may rust or corrode from the inside.(2b) avoid excess moisture (for example, do not leave your chair in a damp bathroom while taking a shower).If you fail to heed these warnings damage to your chair, a fall, tip-over or loss of control may occur and cause severe injury to the rider or others." quickie 2 owner manual, mk-100070, rev f, page 10: "i.Transfers - warning: it is dangerous to transfer on your own.It requires good balance and agility.Be aware that there is a point during every transfer when the wheelchair seat is not below you.To avoid a fall: (1) work with your health care advisor to learn safe methods for transfers.(a) learn how to position your body and how to support yourself during a transfer.(b) have someone help you until you learn safe transfer methods.(2) lock the rear wheels before you transfer.(3) be aware that the chair can still slide and/or tip.The wheel lock keeps the rear wheels from rolling while you are performing the transfer.(4) make sure that the pneumatic tires are properly inflated.Low tire pressure may allow the rear wheel locks to slip.(see table in section g "pneumatic tires")." quickie 2 owner manual, mk-100070, rev f, page 13: "g.Pneumatic tires - warning: (1) do not use this chair if any of the tires are under- or over-inflated.Check weekly for proper inflation level, as listed on the tire sidewall.(2) low pressure in a rear tire may cause the wheel lock on that side to slip and allow the wheel to turn when you do not expect it." quickie 2 owner manual, mk-100070, rev f, page 13: "h.Positioning belts (optional) - warning: the positioning belt is predominately used to support your posture.It can also be used to limit slipping and/or sliding that you might experience when the chair is in motion." quickie 2 owner manual, mk-100070, rev f, page 16: "g.Wheel locks - warning: wheel locks are installed at sunrise and should be adjusted by your qualified service person.Inspect wheel locks weekly per the maintenance chart.Do not use your chair unless you are sure both wheel locks can fully engage.A wheel lock that is not correctly adjusted may allow your chair to roll, or turn unexpectedly.Wheel locks must be adjusted after making sure the tires have the correct air pressure.When fully engaged, the arm should be embedded into the tire at least 1/8" to be effective.If you find the wheel locks have slipped or are not working correctly contact your service provider for proper adjustment." discussion: as a home-use device, the owner manual describes numerous reasons that might contribute to wheel lock slippage.These warnings have been provided to the complainant upon the purchase of the wheelchair and these warnings have been outlined above.In short, the wheelchair should not be used in a wet environment and wheel inflation may contribute to wheel lock slippage.Therefore, it is up to the user to inspect the tire inflation regularly and to avoid wet environments to reduce the risk of wheel lock slippage.The complainant did not describe whether the fall occurred while he was transferring into or out of the shower, or while being used in the shower.Conclusion: the end user used the wheelchair in a manner that is contraindicated for its use and resulted in an injury.No defects were identified during the investigation or in the production records that were directly related to the wheelchair itself.Since the wheelchair was not returned for further investigation, possible contributory factors include (1) lack of sufficient inflation in the wheels to firmly secure the wheel locks in place (2) use of the wheelchair in a wet environment causing the wheel locks to slip when force was applied during transferring or use.No further investigation will be performed as both causes are categorized as user misuse.Sunrise medical considers this case closed.
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On 8-feb-2021 it was reported to sunrise medical that the complainant claims he was using the quickie sunrise wheelchair on (b)(6) 2020 when he fell out of it in the shower "due to the wheel locks." complainant reported pain in his right femur and sought medical treatment.Medical professionals diagnosed the complainant with a fractured femur and treatment consisted of surgical correction of fractured femur and follow-up medical care to ensure healing fracture.There was no further explanation of what he meant by "due to the wheel locks" and he would provide no further information.On (b)(6) 2020, the complainant went to the emergency department (ed) due to the fall at home in shower and had severe pain in his right leg and was unable to move his leg.His physical examination revealed tenderness over the right lower extremity.He underwent an x-ray of right lower extremity, from hip, femur to ankle, which revealed displaced and angulated fracture through the mid to distal right femur.Patient was diagnosed with the following: right femoral shaft fracture secondary to fall.Unspecified intracapsular fracture of right femur.Diagnosis code: (b)(4).Patient was hospitalized and underwent surgery on (b)(6) 2020 with an orif (open reduction internal fixation) repair with retrograde nail (rod).Post hospital discharge, he was continued with pain management, physical therapy, and occupational therapy.Patient was discharged from further medical treatments after release from care on (b)(6) 2020 when medical examination determined no evidence of complication and stable alignment of healed fracture.Note: this mdr is filed one day late due to technical difficulties with the esubmitter software.Please reference esubmitter help desk ticket dated 11-mar-2021 10:47am.
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