MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE; POWER WHEELCHAIR

Model Number QUICKIE QM710

Device Problems Mechanical Problem (1384); Mechanical Jam (2983); Noise, Audible (3273)

Patient Problems Multiple Fractures (4519); Subluxation (4525); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2021

Event Type  Injury  

Manufacturer Narrative

Background information: the quickie qm710 owner manual (mk-100158, rev g, section j, page 12) states: "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." and "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." discussion: sunrise wheelchairs are provided with positioning belts upon request.The determination of whether a positioning belt is needed is the dealer/provider responsibility to specify as some users may be determined, by a mobility specialist, to be in need of positioning belts as they have sufficient physical strength and posture to not be a requirement.This requirement cannot be determined by sunrise medical as we do not know the condition of the end user, nor the specific needs of their disability.The subject product was ordered with a positioning belt, however, is fairly certain that the end user was not using his positioning belt at the time of the incident as it has a high likelihood of preventing falls in the cases of direction changes or abrupt halts of the wheelchair.The claim of the "left motor locked up" may be due to one of two potential causes: the motor brake faulted and engaged.This would result in what is called a "soft stop" where the wheels slow down to a stop which may feel somewhat sudden, but the wheel itself does not stop spinning, but will roll to a fairly quick stop.A gear dislocated from its location and caused the wheel itself to stop spinning which would result in a sudden stop of all movement on the affected wheel.The symptoms of this type of this malfunction (occurring on one side) would result in a ¼ turn/spin around the stopped wheel.A stopped left wheel would cause an abrupt 90° turn to the left.This could result in a user falling out of the wheelchair onto their right side.The claims of injury are suspect in that no medical attention was sought to diagnose or treat the alleged injuries.However, a fall from the wheelchair does have the potential for leading to a serious injury.Finally, the subject wheelchair is almost one year past its useful lifetime (5 years 8 months of age).Aging of components could be a contributory factor to the malfunction.Conclusion: the use of the positioning belt (equipped with this chair) could have prevented the fall, however, the end user for reasons unknown did not have their positioning belt on.The claim of the "left motor locked up" is reported as a malfunction and, with a resultant fall, has a potential for leading so serious injury.It is unknown at this time what, if any, injuries the end user suffered as there has been no proven claim of injury nor medical diagnosis.Should additional information arise in the future, sunrise medical will file a supplemental report.

Event Description

According to end user, he was driving down the street when the left side motor of his powered wheelchair locked up causing the chair to come to an abrupt halt.The end user fell out of the wheelchair and claims to have suffered numerous injuries (1) broken ribs, (2), dislocated shoulder, and (3) a possible broken leg.None of these claims have been substantiated by a medical professional.It is possible that these are fraudulent claims.

Manufacturer Narrative

Background information: the qm-71-/715hd/720 (mk-100158 rev a) section vi.H.States: "the frame, motors and other chair parts are not water-tight and may rust or corrode from the inside.", "to avoid a chair failure: minimize exposure of your chair to rain or very wet conditions."; "do not use your chair in fresh or salt water (such as at the edge of a stream, lake, or ocean)"; "dry the chair as soon as you can if it gets wet, or if you use water to clean it." and "prevent the wheelchair from coming into contact with sea water: sea water is caustic and may damage the wheelchair." the use fmea "ufmea_power product_master.Xlsm", risk id 283 states that the corrosion of the brake assembly can lead to brake binding or loss of function.Discussion: while performing a retrospective review for this complaint another failure mode was identified as most likely to have led to the reported failure, though no return has been made available to confirm the most probable failure mode.It was noted that in cases of returned product where individual motors lock up it is most likely a result of corrosion in the motor.The previously identified causes remain possible, however they are not the most probable.For the brake or controller fault the most probable effect is both motors locking up which did not occur in this case, while a possible gear dislocation would most probably lead to a freewheel condition rather than a motor lockup.Sunrise wheelchair motors are subject to iso 7176-09 climatic testing, which includes evaluation of protection against ingress of liquids and resistance to condensation.These tests are intended to determine the effects of rain, dust and condensation on the basic functioning of electrically powered wheelchairs however the product is not designed with the intent that the chair be subject to immersion in water or repeat exposure to fluids and warnings for this are captured in the owners manual.Conclusion: it is most probable that a corroded state of the motor led to the reported malfunction.With proper care as defined in the owners manual the risk of corrosion can be reduced.The risk of brake binding leading to the user falling out of the seat has a potential for leading to serious injury which can be mitigated through the use of the positioning belt.This complaint was re-evaluated during a retrospective review and remediation effort resulting from improvements made to the company's complaint handling and adverse event reporting processes to ensure patient safety and regulatory compliance.This mdr is being filed based on the outcome of that retrospective review.

Event Description

Please see initial mdr 2937137-2021-00029.

• Brand Name: QUICKIE
• Type of Device: POWER WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park avenue; fresno CA 93727 1328
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727-1328 ; 5592942374
• MDR Report Key: 12284906
• MDR Text Key: 265397445
• Report Number: 2937137-2021-00029
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00016958052367
• UDI-Public: (01)00016958052367
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QUICKIE QM710
• Device Catalogue Number: EIPW11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 54 KG