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

Model Number QUICKIE SR45

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

Background information: quickie sr45 owner manual, 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.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.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." quickie sr45 owner manual, rev.D 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 reports that the left and right side push wheel lock's hardware is loosening and coming out.It was determined that based on similar complaints and products received, the potential cause could be hardware loosening over time which would lead to insufficient wheel locking force.This potential cause is currently under review and additional information about the wheel locks is being requested for review.Based on the owner's manual, the user or dealer should be performing maintenance to reduce the risk of wheel locks becoming non-functional or broken.The end user's brother attempted to push the bolt and washer back into place, but the hardware loosened again and did not hold for an extended period of time.The age of the chair at the time of this complaint was approximately 441 days.There were no injuries or adverse impact to the user reported.Conclusion: in conclusion, the loosening of the wheel lock hardware over time is the primary potential cause identified.The investigation into the matter is ongoing.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.Because the failure mode of non-functioning wheel locks has been previously reported, per 21 cfr 803.50, this mdr is being filed.

Event Description

Dealer reports that the left and right side push wheel lock's hardware is loosening and coming out.The end user's brother attempted to push the bolt and washer back into place, but the hardware loosened again and did not hold for an extended period of time.No injuries or adverse impact to the user was reported.

• Brand Name: QUICKIE
• Type of Device: MECHANICAL 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 ; 5592942374
• MDR Report Key: 17980835
• MDR Text Key: 326269527
• Report Number: 9616084-2023-00063
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00016958053661
• UDI-Public: 00016958053661
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• 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: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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