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

Model Number	QUICKIE 2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the dealer, the wheelchair's left-side wheel lock became loose; this occurred while the end-user used the chair on (b)(6) 2024.The dealer reported the technician went to the end user's home to tighten the wheel lock three (3) separate times, but the left-side wheel lock will no longer remained tightened.The dealer did not report any injuries or adverse impact to the end user, and the dealer requested a warranty replacement of the left-side wheel lock assembly.
Additional Manufacturer Narrative
Background information: quickie 2 wheelchair owner's manual, rev.F, states: "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 embedded into the tire at least 1/8' to be effective." it further provides that "if you find the wheel locks have slipped or are not working correctly contact your service provider for proper adjustment." quickie 2 wheelchair owner's manual, rev.F, 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 stated the wheelchair's left-side wheel lock became loose; this occurred while the end-use used the chair on (b)(6) 2024.Based on similar complaints and products received, the potential cause could be hardware loosening over time leading to an 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 end user or dealer should be performing maintenance checks to reduce the risk of wheel locks becoming non-functional or broken.The dealer reported the technician went to the end-user's home to tighten the wheel lock three (3) separate times, but the left-side wheel lock will no longer remained tightened.At the time of the complaint, the chair was approximately 129 days.According to the quickie 2 wheelchair owner's manual, sunrise medical provides a one-year warranty from the date of purchase for all sunrise-made parts and components with defects in their material or workmanship.Therefore, the dealer requested a warranty replacement of the left-side wheel lock assembly.There were no reports of injury or adverse impact to the end user.Conclusion: the primary potential cause identified is the loosening of the wheel lock's hardware over time.At the time of shipping to the customer, the product in question met all product specifications before release for distribution.This device is used for treatment, not diagnosis.There is no claim of injury in this case.Because the failure mode of the non-functioning wheel locks has been previously reported, this mdr is being filed in accordance with per 21 cfr 803.50.

• Brand Name: QUICKIE
• Common Device Name: 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: 20301708
• Report Number: 9616084-2024-00046
• Device Sequence Number: 7791492
• Product Code: IOR
• UDI-Device Identifier: 00016958043815
• UDI-Public: (01)00016958043815
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K123975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: QUICKIE 2
• Device Catalogue Number: EIQ2X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 120 KG