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

Model Number QUICKIE SR45

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/09/2022

Event Type  malfunction  

Event Description

It was reported by the dealer that a screw on the left side "push to lock" wheel lock came off and the wheel lock is no longer holding.Reported by atp that it was not working, client was dropped off by family at clinic, client does not speak.No injuries or adverse impact to the user was reported.

Manufacturer Narrative

Background information: all owner manuals contain information regarding maintenance schedules for manual and power wheelchairs.It is the dealer's responsibility to make sure that users return on a scheduled basis to maintain their wheelchairs properly.This maintenance requirement includes all fasteners (nuts, bolts, etc.) are securely fastened, there is no unusual wear and tear on mechanical items, and electronic items are fully functional.It is the dealer's responsibility to ensure that maintenance requirements are communicated to the user, and failure to adhere to the manufacturer's maintenance requirements is a failure on the part of the dealer and/or end user.Some items (e.G., batteries, struts, etc.) require replacement at scheduled intervals as provided in the instructions for use (ifu) that is provided with every sunrise medical product.These maintenance schedules are provided so that both the dealers and the users have specific information regarding the frequency of preventive and routine maintenance and certain issues to watch for (e.G., loose bolts, worn straps, batteries not retaining a charge, worn tires, etc.).Adherence to these maintenance schedules is crucial for the continued safe functioning and use of the products.If these maintenance schedules are not adhered to injury may result.Chairs are subject to static, fatigue and impact testing per the requirements of ansi/resna or iso (b)(4) section 8 to ensure integrity of the chair for the life of the device.This potential failure mode associated to loosening wheel lock hardware is addressed in ufmea_manual tilt wheelchairs master - risk id #: (b)(4).The quickie sr 45 owner manual (118611 rev d) states: "warning rear wheel locks are not designed to slow or stop a moving wheelchair.Use them only to keep the rear wheels from rolling when your chair is at a complete stop.Never use rear wheel locks to try to slow or stop your chair when it is moving.Doing so may cause a fall or tip-over.To keep the rear wheels from rolling, always set both rear wheel locks when you transfer to or from your chair.Low pressure in a rear tire may cause the wheel lock on that side to slip and may allow the wheel to turn when you do not expect it.Make sure lock arms embed in tires at least 1/8 inch when locked.If you fail to do so, the locks may not work.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."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 imbedded 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." the functionality and effectiveness of wheel locks on manual wheelchairs is dependent on a variety of factors including position of the wheel lock relative to the rear wheel, accessibility of the actuation lever to the rider and proximity of the mechanism to other accessories and components mounted to the chair.The combination of these factors makes the ideal positioning of the wheel lock unique to each device.In addition, it is foreseeable that manual wheelchairs will be adjusted and reconfigured in the field to meet the changing needs of the rider.As a result, wheel locks on manual wheelchairs are purposefully designed with a high level of adjustability which allows them to function properly in all required unique mounting locations while providing the flexibility required to meet the changing needs of the wheelchair rider.Removing this adjustability would limit available configurations and force the rider to compromise their optimal seating position or potentially affect the overall effectiveness of the wheel locks.Discussion: all sunrise medical manual wheelchairs are provided with wheel locks.After evaluating the complaint, it was determined that the user's claim was attributed to loosening of the wheel lock hardware over time.The determination of what type of wheel locks the user needs is the dealer/provider's responsibility based on the user's condition.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.Conclusion: based on the ifu, the user or dealer should be performing maintenance to reduce the risk of wheel locks becoming non-functional or broken.The product in question met all product specifications before release for distribution at the time of shipping to the customer.This device is used for treatment, not diagnosis.There is no claim of injury in this case.The failure mode of non-functioning wheel locks has been previously reported per 21 cfr 803.50.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.Should additional information become available, sunrise medical will file a supplemental report.

• Brand Name: QUICKIE WHEELCHAIR
• Type of Device: WHEELCHAIR MECHANICAL
• 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: 17097643
• MDR Text Key: 317529475
• Report Number: 9616084-2023-00029
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123975
• 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: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QUICKIE SR45
• Device Catalogue Number: EIZ9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2022
• 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 Age: 51 YR
• Patient Weight: 73 KG