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

Model Number QUICKIE IRIS

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

The dealer reported that the left and right side wheel locks were loose.A technician with numotion went to the end user's home 3 times to tighten the wheel locks, but it did not work.No injuries or adverse impact to the user was reported.

Manufacturer Narrative

Background information: quickie iris wheelchair 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 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 iris wheelchair owner manual, rev.D 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 iris wheelchair 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 reported that the left and right-side wheel locks were extremely loose.It was determined that based on similar complaints and products received, the potential cause could be hardware loosening over time which could lead to insufficient wheel locking force.A dhr review for this product was conducted and no abnormalities, deviations or ncmr's related to the claim were identified in the manufacturing process 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.A technician went to the end user's home 3 times to tighten the wheel locks, but it did not work.The age of the chair at the time of this complaint was approximately 127 days.According to the quickie iris 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 the left and right hand wheel locks.There were no injuries or adverse impact to the user reported.Conclusion: on january 26, 2024, quality engineering updated the failure analysis referencing a failure mode tied to a sentinel event.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.Because the failure mode of non-functioning wheel locks has been previously reported, per 21 cfr 803.50, this mdr is being filed.

• 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 TECNOLOGIAS S.A. DE CV; privada misiones no. 110; parque industrial misiones; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: christian stephens ; 2842 n business park ave; fresno, CA 93727
• MDR Report Key: 18631923
• MDR Text Key: 334746609
• Report Number: 9616084-2024-00002
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00016958046861
• UDI-Public: 00016958046861
• 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 IRIS
• Device Catalogue Number: EIZ4-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2023
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Weight: 91 KG