BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE

    MDR report key: 21819902 · Received April 10, 2025

    Report

    Report Number
    9616084-2025-00043
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 10, 2025
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K072153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BACKGROUND INFORMATION: QUICKIE QX/QXI WHEELCHAIR OWNER'S MANUAL, REV. H, PAGE 14 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 QX/QXI WHEELCHAIR OWNER'S MANUAL, REV. H, PAGE 28 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 END USER REPORTED THAT THE WHEEL LOCKS WERE NOT LOCKING TO THE WHEELS PROPERLY. THE DEALER STATED THAT UPON FURTHER INVESTIGATION, THE TECHNICIAN FOUND THAT BOTH WHEEL LOCKS WERE MISSING THE BOLTS FROM THE ASSEMBLY. 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. THE TECHNICIAN REPORTED TO THE DEALER THAT THEY APPLIED LOCTITE ON THE WHEEL LOCKS, BUT THE PROBLEM PERSISTED. SUNRISE MEDICAL DOES NOT RECOMMEND THE USE OF LOCTITE ON THE HARDWARE RELATED TO WHEEL LOCKS. THE AGE OF THE CHAIR AT THE TIME OF THIS COMPLAINT WAS APPROXIMATELY THREE HUNDRED AND TWENTY-NINE (329) DAYS. ACCORDING TO THE QUICKIE QXI 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. THEREFORE, THE DEALER REQUESTED A WARRANTY REPLACEMENT OF BOTH WHEEL LOCK ASSEMBLIES. 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 DEALER. 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.

    Description of Event or Problem · 0

    THE DEALER STATED THE END USER REPORTED THAT THE WHEEL LOCKS WERE NOT LOCKING TO THE WHEELS PROPERLY. THE DEALER STATED THAT UPON FURTHER INVESTIGATION, THE TECHNICIAN FOUND THAT BOTH WHEEL LOCKS WERE MISSING THE BOLTS FROM THE ASSEMBLY. THE TECHNICIAN REPORTED TO THE DEALER THAT THEY APPLIED LOCTITE ON THE WHEEL LOCKS, BUT THE PROBLEM PERSISTED. SUNRISE MEDICAL DOES NOT RECOMMEND THE USE OF LOCTITE ON THE HARDWARE RELATED TO WHEEL LOCKS. THE DEALER REQUESTED A WARRANTY REPLACEMENT OF BOTH WHEEL LOCK ASSEMBLIES. NO INJURIES OR ADVERSE IMPACT TO THE USER WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911791 QUICKIE MECHANICAL WHEELCHAIR IOR SUNRISE MEDICAL (US) LLC QUICKIE QXI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown