BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE WHEELCHAIRS

    MDR report key: 17119413 · Received June 13, 2023

    Report

    Report Number
    2937137-2023-00014
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    August 18, 2021
    Report Date
    June 13, 2023
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BACKGROUND INFORMATION: THE QUICKIE Q300M MINI OWNER MANUAL (253033 REV A) STATES: "DO NOT DRIVE THROUGH PUDDLES OF WATER" AND "NEVER TAKE YOUR CHAIR INTO A SHOWER, TUB, POOL, OR SAUNA." AND "DRY THE CHAIR AS SOON AS YOU CAN IF IT GETS WET, OR IF YOU USE WATER TO CLEAN IT." AND "PREVENT THE WHEELCHAIR FROM COMING INTO CONTACT WITH SEA WATER: SEA WATER IS CAUSTIC AND MAY DAMAGE THE WHEELCHAIR." WHILE ALSO PROVIDING FIGURE 3.22 WITH GUIDANCE FOR NOT EXPOSING THE CHAIR OR THE CONTROL DEVICE TO WATER (PAGE 8). THE QUICKIE SEDEO PRO OWNER MANUAL (248020 REV. E) ALSO STATES THAT "THE POSITIONING BELT IS PREDOMINATELY USED TO SUPPORT YOUR POSTURE. IT CAN ALSO BE USED TO LIMIT SLIPPING AND/OR SLIDING THAT YOU MIGHT EXPERIENCE WHEN THE SYSTEM IS IN MOTION." AND "IF YOU FAIL TO HEED THESE WARNINGS, DAMAGE TO YOUR SYSTEM, A FALL, TIP-OVER, OR LOSS OF CONTROL MAY OCCUR AND CAUSE SEVERE INJURY TO THE RIDER OR OTHERS. " (PAGE 9). THE USE FMEA "UFMEA_POWER PRODUCT_MASTER.XLSM", RISK ID 283 STATES THAT THE CORROSION OF THE BRAKE ASSEMBLY CAN LEAD TO BRAKE BINDING OR LOSS OF FUNCTION. DISCUSSION: SUNRISE WHEELCHAIRS ARE PROVIDED WITH POSITIONING BELTS UPON REQUEST. THE DETERMINATION OF WHETHER A POSITIONING BELT IS NEEDED IS THE DEALER/PROVIDER RESPONSIBILITY TO SPECIFY AS SOME USERS MAY BE DETERMINED, BY A MOBILITY SPECIALIST, TO BE IN NEED OF POSITIONING BELTS AS THEY HAVE SUFFICIENT PHYSICAL STRENGTH AND POSTURE TO NOT BE A REQUIREMENT. THIS REQUIREMENT CANNOT BE DETERMINED BY SUNRISE MEDICAL AS WE DO NOT KNOW THE CONDITION OF THE END USER, NOR THE SPECIFIC NEEDS OF THEIR DISABILITY. THE SUBJECT PRODUCT WAS ORDERED WITH A POSITIONING BELT. SUNRISE WHEELCHAIR MOTORS ARE SUBJECT TO ISO 7176-09 CLIMATIC TESTING, WHICH INCLUDES EVALUATION OF PROTECTION AGAINST INGRESS OF LIQUIDS AND RESISTANCE TO CONDENSATION. THESE TESTS ARE INTENDED TO DETERMINE THE EFFECTS OF RAIN, DUST AND CONDENSATION ON THE BASIC FUNCTIONING OF ELECTRICALLY POWERED WHEELCHAIRS HOWEVER THE PRODUCT IS NOT DESIGNED WITH THE INTENT THAT THE CHAIR BE SUBJECT TO IMMERSION IN WATER OR REPEAT EXPOSURE TO FLUIDS AND WARNINGS FOR THIS ARE CAPTURED IN THE OWNERS MANUAL. AFTER EVALUATING THE RETURN MOTOR, THE CLAIM THAT THE RIGHT MOTOR "LOCKS UP AT TIMES" WAS FOUND TO BE ATTRIBUTED TO CORROSION OF THE MOTOR HAVING LED TO BRAKE BINDING WHICH WOULD CAUSE SUDDEN STOPPAGE OF THE CHAIR DUE TO INTERFERENCE OF MECHANICAL ELEMENTS IN THE MOTOR. CORROSION MAY BE ATTRIBUTED TO REPEAT OR PROLONGED EXPOSURE TO CORRODING ELEMENTS SUCH AS WATER, HUMAN EXCRETA OR CLEANING AGENTS. AT THE TIME OF COMPLAINT THE CHAIR WAS 2 MONTHS OLD. CONCLUSION: THE CORRODED STATE OF THE MOTORS LED TO THE REPORTED MALFUNCTION. WITH PROPER CARE AS DEFINED IN THE OWNERS MANUAL THE RISK OF CORROSION CAN BE REDUCED. THE RISK OF BRAKE BINDING LEADING TO THE USER FALLING OUT OF THE SEAT HAS A POTENTIAL FOR LEADING TO SERIOUS INJURY WHICH CAN BE MITIGATED THROUGH THE USE OF THE POSITIONING BELT. THERE IS NO CLAIM OF INJURY IN THIS CASE. BECAUSE THE CORROSION LEADING TO BRAKE BINDING FAILURE MODE HAS BEEN REPORTED IN A SERIOUS INJURY COMPLAINT HOWEVER SUNRISE MEDICAL IS FILING THIS MDR. SHOULD ADDITIONAL INFORMATION ARISE IN THE FUTURE, SUNRISE MEDICAL WILL FILE A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    DEALER REPORTS THAT THE WHEELCHAIR "LOCKS UP" AT TIMES AND HAS ALMOST CAUSED THE END USER TO BE THROWN FROM THE DEVICE. THE DEALER ALSO REPORTS THAT THE RIGHT MOTOR IS MAKING A LOUD WINDING SOUND. THE WHEELCHAIR WAS RETURNED AND EVALUATED BY A SUNRISE MEDICAL RESEARCH & DEVELOPMENT TECHNICAL EXPERT. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206920 QUICKIE WHEELCHAIRS WHEELCHAIR POWERED ITI SUNRISE MEDICAL (US) LLC QUICKIE Q300M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown