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

Model Number QUICKIE 2

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

Background information: quickie 2 wheelchair owner's manual, rev.F, page 16 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, page 31 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 bolt on the left side push wheel lock is loose.Based on similar complaints and products received, the potential cause could be hardware loosening over time leading 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 checks to reduce the risk of wheel locks becoming non-functional or broken.The dealer stated that he has tightened the bolt to secure the wheel lock, but the wheel lock begins to come loose, making it unable to be engaged.At the time of the complaint, the chair was approximately 171 days.According to the quickie 2 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 wheel lock.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

Dealer reports that the bolt on the left side push wheel lock is loose.The dealer stated that he has tightened the bolt to secure the wheel lock, but the wheel lock becomes loose and unable to be engaged.The dealer did not report any injuries or adverse impact to the user.A warranty replacement of the left wheel lock was requested.

• 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: 18753811
• MDR Text Key: 336867211
• Report Number: 9616084-2024-00003
• 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: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: QUICKIE 2
• Device Catalogue Number: EIQ2X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/04/2023
• 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