The initial complaint of the foot plate falling forward did not actually cause the incident.The incident was caused by the end user grabbing the joystick while not seated in the chair.The chair was obviously powered up during the transfer and the wheel locks were not engaged.In addition, there is no indication that anyone was present when she attempted the transfer.Per the warnings in the quickie pulse owner manual (119832, rev h, page 9) these activities are contraindicated for safe transfers.The owner manual states "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 prevent a fall: 1.Always turn off power before you transfer to or from your chair.If you fail to do so you may touch the joystick and cause your chair to move when you do not expect it.2.Make sure motor brakes are engaged.This keeps the chair from moving when you transfer.3.Work with your health care professional to learn all safe methods for transfers.· learn how to position your body and how to support yourself during a transfer.· have someone help you until you are sure you can do a safe transfer on your own." these warnings regarding turning off the wheelchair and engaging the wheel locks were not adhered to and, therefore, a fall occurred.In addition, there is no indication that a second party was present during the incident.Therefore, there is no malfunction of the product that contributed to the fall and resultant injury.The extent of the reported injury "pelvic fracture" was not described and, therefore, cannot be categorized.Medical visits, diagnosis, treatment, and possible future treatments were not described.Therefore, out of an abundance of caution, this mdr is being filed for this incident.There was no medical confirmation of the diagnosis of a "fractured pelvis," nor any medical treatments applied, nor future need supplied.Fractures (i.E., broken bones" can be categorized as (1) incomplete/greenstick fracture, (2) complete fractures: fracture with or without displacement of bone ends, or (3) multiple bone breaks) and can be ranked in severity.It is impossible to know, without medical tests, diagnosis, or treatment into which category this fracture would fall.Therefore, sunrise has determined to file incident this as a "serious injury" in the absence of medical data.This filing is done out of an abundance of concern and not due to objective, medical data.The need for future medical treatments are unreported and unknown.In reviewing the historical data for the serial number of this chair, there have been no past orders for replacement parts from the end user or any dealer.Therefore, sunrise cannot confirm that all required maintenance has been performed, nor have there been any complaints called into sunrise medical on this chair.The age of the chair at the time of the incident was 9 months 9 days.Per the quickie pulse owner manual, page 17, the following safety and function checks are required."· daily: charge batteries · weekly: check tires for proper inflation · monthly: check plugs and connectors for proper connections · quarterly: (1) check all moving parts for wear (2) inspect all nuts, bolts and fasteners for looseness or wear (3) inspect upholstery for wear." since the complaint stated that "the foot plate keeps falling down and hitting the end user" and "that the foot plate fell down and hit the end user's ankle" and finally "the footrest fell forward and pushed [the end user]" caused the end user to grab the armrest, it is likely that the lack of safety and function checks may have resulted in a loose part (the footrest).However, without performing regular safety & function checks on the product, this may have been caught prior to the incident and the fall may have been prevented; if the footplate was indeed the cause of the incident.According to sunrise records, no maintenance, parts orders, nor service requests have been submitted for this serial number since the chair was sold in (b)(6) 2019.This would mean that no parts were ordered by anyone for repairs, nor was routine service or maintenance performed by sunrise.A call was made to the dealer (b)(4) and srm representative spoke to a cms customer service representative.Their records show that the chair was delivered to the end user on (b)(6)2019.On (b)(6) 2019, the end user returned to chair to capital medical supply complaining that the "footplate was too tight." this complaint was not called into sunrise medical.In addition, normal servicing was performed and the back was adjusted for the end user.It is most likely that the footplate was loosened at that time.No further activities have been performed by capital medical supply since that date.Finally, the current incident was reported in (b)(6) 2020 and claim that the injury was suffered in (b)(6) 2020 (4 months after the alleged incident).There is no explanation from the end user or her daughter-in-law of why there was a four-month delay in report of injury.It is believed, considering the lack of medical evidence, that this may be a false report.In addition, it appears that the footplate being loosened in (b)(6) 2019 may have been the direct cause of the current complaint "the foot plate keeps falling down and hitting the end user." footplates, when assembled on wheelchairs by srm during manufacture are tightened sufficiently (to specification) to prevent footplates from falling down inadvertently.Loosening of this foot plate directly resulted in the foot plate falling.Conclusion: the claim of "foot plate keeps falling down and hitting the end user" can be directly related to the loosening of the footplate by capital medical supply performed in (b)(6) 2019.The claim of "fractured pelvis" cannot be verified by any objective means and may be a false claim; however, an mdr is being filed out of an abundance of caution on the part of sunrise medical.If any additional details or medical diagnosis/treatment and medical professional confirmation of injuries is performed; a supplement will be filed.Otherwise, this issue is considered closed by sunrise medical with no further actions.
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