BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE

    MDR report key: 20797596 · Received November 27, 2024

    Report

    Report Number
    9616084-2024-00079
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 27, 2024
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K072153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 REPORTED THE LEFT-SIDE WHEEL LOCK'S NUT, WHICH CONNECTS THE BOLT TO THE MAIN ASSEMBLY, WAS MISSING. 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 AGE OF THE CHAIR AT THE TIME OF THIS COMPLAINT WAS APPROXIMATELY SIXTY-SIX (66) 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. THE DEALER REQUESTED A WARRANTY REPLACEMENT OF THE LEFT-SIDE WHEEL LOCK ASSEMBLY. 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 REPORTED THE LEFT-SIDE WHEEL LOCK'S NUT, WHICH CONNECTS THE BOLT TO THE MAIN ASSEMBLY, WAS MISSING. THE DEALER REQUESTED A WARRANTY REPLACEMENT OF THE LEFT-SIDE WHEEL LOCK ASSEMBLY. NO INJURIES OR ADVERSE IMPACT TO THE USER WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367439 QUICKIE MECHANICAL WHEELCHAIR IOR SUNRISE MEDICAL (US) LLC QUICKIE QXI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown