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

Model Number QUICKIE ACCESS

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

Background information: quickie access wheelchair owner manual, page 13 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.1.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.2.To keep the rear wheels from rolling, always set both rear wheel locks when you transfer to or from your chair.3.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.4.Ensure lock arms embedded 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." quickie access wheelchair owner manual, page 16 states: "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." quickie access wheelchair owner manual, page 29 states: "we warrant all sunrise-made parts and components of this wheelchair against defects in materials and workmanship for one year from the date of first consumer purchase." discussion: in evaluating the complaint, the dealer reported the left and right wheel locks kept coming loose.Based on similar complaints and products received, the potential cause could be hardware loosening over time leading to insufficient wheel locking force.Based on the owner's manual, the user or dealer should be performing maintenance checks to reduce the risk of wheel locks becoming non-functional or broken.When the wheel locks became loose, the user/dealer had to retighten the assembly and after a nonspecific period of time, the wheel locks would become loose again having to constantly retighten the assembly once the cycle repeats.At the time of the complaint, the chair was approximately 196 days.According to the quickie access wheelchair owner's manual, sunrise medical provides a one-year warranty from date of purchase for all sunrise-made parts and components that have defects in the material or workmanship.The dealer requested a warranty replacement of both wheel locks.There were no injuries or adverse impact to the user reported.Conclusion: the loosening of the wheel lock hardware over time is the primary potential cause identified.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.Per 21 cfr 803.50, this mdr is being filed because the failure mode of non-functioning wheel locks has been previously reported.

Event Description

The dealer reported that they had to constantly tighten the left and right wheel locks because they kept coming loose and would not hold up.The dealer did not report any injuries or adverse impact to the user.

• Brand Name: QUICKIE
• Type of Device: MECHANICAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno, ca 93727 ; MX 93727
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727
• MDR Report Key: 18636587
• MDR Text Key: 334552036
• Report Number: 2937137-2024-00001
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00016958059410
• UDI-Public: 00016958059410
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QUICKIE ACCESS
• Device Catalogue Number: EIR14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2023
• 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: 61 KG