BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE

    MDR report key: 17882157 · Received October 5, 2023

    Report

    Report Number
    9616084-2023-00058
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 6, 2023
    Report Date
    January 31, 2025
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K072153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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: AFTER EVALUATING THE COMPLAINT, THE DEALER REPORTS THAT THE LEFT SIDE PUSH WHEEL LOCK HARDWARE IS BECOMING LOOSE. IT WAS DETERMINED THAT BASED ON SIMILAR COMPLAINTS AND PRODUCTS RECEIVED, THE POTENTIAL CAUSE COULD BE HARDWARE LOOSENING OVER TIME LEADING TO INSUFFICIENT WHEEL LOCKING FORCE. THIS POTENTIAL CAUSE IS CURRENTLY UNDER REVIEW AND ADDITIONAL INFORMATION ABOUT THE WHEEL LOCKS ARE 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 DEALER HAS RETIGHTENED THE HARDWARE MULTIPLE TIMES, BUT IT CONTINUES TO LOOSEN. THE AGE OF THE CHAIR AT THE TIME OF THIS COMPLAINT WAS APPROXIMATELY 126 DAYS. ACCORDING TO THE QUICKIE QX/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 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.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY. THIS MDR ONLY CONTAINED THE DI PORTION OF THE UDI INCLUDED IN THE MEDWATCH FORM. THE MDR HAS BEEN CORRECTED BY ADDING THE FULL UDI NUMBER.

    Description of Event or Problem · 0

    DEALER REPORTED THAT THE LEFT SIDE PUSH WHEEL LOCK HARDWARE IS BECOMING LOOSE. THE DEALER HAS RETIGHTENED THE HARDWARE MULTIPLE TIMES BUT IT CONTINUES TO LOOSEN. THE DEALER HAS REQUESTED A REPLACEMENT OF THE LEFT SIDE WHEEL LOCK. NO INJURIES OR ADVERSE IMPACT TO THE USER WAS REPORTED.

    Description of Event or Problem · 0

    THIS REPORT REPRESENTS A CORRECTION TO A PREVIOUSLY SUBMITTED MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156903 QUICKIE MECHANICAL WHEELCHAIR IOR SUNRISE MEDICAL (US) LLC QUICKIE QXI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown