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

Model Number QUICKIE Q500M

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2022

Event Type  malfunction  

Event Description

The dealer claims the right motor is freewheeling constantly and will not lock in.Claims no signs of external damage.No injuries to claim.

Manufacturer Narrative

Background information: the quickie q500 m / q400 m general manual (248035 rev h) states: "do not drive through puddles of water" and "never take your chair into a shower, tub, pool, or sauna." and "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." while also providing figure 3.22 with guidance for not exposing the chair or the control device to water (page 9).The quickie captain seat owner manual (247975 rev.B) also states that "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 system is in motion." (page 8) and "always wear a positioning belt." (page 6) and "if you fail to heed these warnings, damage to your system, a fall, tip-over, or loss of control may occur and cause severe injury to the rider or others." (page 8).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: 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.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.After evaluating the return motor, the claim that the "motor is freewheeling constantly.Will not lock in" was found to be attributed to corrosion of the motor.Corrosion may be caused by repeat or prolonged exposure to corroding elements such as water, human excreta or cleaning agents.At the time of complaint the chair was 11 months old.Conclusion: the corroded state of the motors led to the reported malfunction.With proper care as defined in the owners manual the risk of corrosion can be reduced.The risk that corrosion leads to brake binding and the user falling out of the seat has a potential for serious injury which can be mitigated through the use of the positioning belt.There is no claim of injury or brake binding in this case, however there has been a case where corrosion led to brake binding and serious injury.Because of this sunrise medical is filing this mdr.Should additional information arise in the future, sunrise medical will file a supplemental report.

• Brand Name: QUICKIE WHEELCHAIR
• Type of Device: WHEELCHAIR, POWERED
• 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 ; 5592942374
• MDR Report Key: 17102334
• MDR Text Key: 317092130
• Report Number: 2937137-2023-00011
• Device Sequence Number: 1
• Product Code: ITI
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QUICKIE Q500M
• Device Catalogue Number: EIPW30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 73 KG