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 06/14/2023

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" and "if you find the wheel locks have slipped or are not working correctly contact your sunrise medical authorized dealer 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 left side push wheel lock is becoming loose due to the pivot bolt and nut separating.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 technician reassembled and tightened the wheel lock initially ; however, on another visit, there were indications that the wheel lock had become loose again.The age of the chair at the time of this complaint was approximately 354 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-hand wheel lock.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.This complaint was re-evaluated during a retrospective review and remediation effort resulting from improvements made to the company's complaint handling and adverse event reporting processes to ensure patient safety and regulatory compliance.This mdr is being filed based on the outcome of that retrospective review.Should additional information become available, sunrise medical will file a supplemental report.

Event Description

Dealer reports that the left side push wheel lock is becoming loose because the pivot bolt and nut separated.The technician reassembled and tightened the wheel lock initially; however, on another visit, there were indications that the wheel lock had become loose again.The dealer requested a warranty replacement on the left hand wheel lock.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: 17980815
• MDR Text Key: 326540055
• Report Number: 9616084-2023-00059
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00016958043815
• UDI-Public: 00016958043815
• 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 2
• Device Catalogue Number: EIQ2X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2022
• 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