BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKIE Q2

    MDR report key: 12281599 · Received August 5, 2021

    Report

    Report Number
    9616084-2021-00034
    Event Type
    Malfunction
    Date Received
    August 5, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 5, 2021
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    IOR
    PMA / PMN Number
    K123975
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE INCIDENT, THE QUICKIE 2 WHEELCHAIR, EQUIPPED WITH ONE-ARM DRIVE, WAS FOUR YEARS OF AGE. AT THIS TIME, THERE IS NO RECORD IN SUNRISE MEDICAL OF ANY REPAIRS, MAINTENANCE, OR PARTS ORDERS (FOR WEARABLE PARTS). THE QUICKIE 2 OWNER MANUAL OUTLINES SPECIFIC REQUIREMENTS FOR USE AND MAINTENANCE (P/N MK-100070, REV F, SECTION VIII, PAGES 15-21) AND SERVICING (SECTION IX, PAGES 22-30). IT IS THE DEALER'S RESPONSIBILITY TO ENSURE THAT USERS RETURN ON A SCHEDULED BASIS TO ENSURE THEIR WHEELCHAIRS ARE MAINTAINED PROPERLY. THIS MAINTENANCE REQUIREMENT INCLUDES SUCH ITEMS AS ENSURING ALL FASTENERS (NUTS, BOLTS, ETC.) ARE SECURELY FASTENED, THERE IS NO INORDINATE WEAR AND TEAR ON MECHANICAL ITEMS, AND THAT ELECTRONIC ITEMS ARE FUNCTIONING FULLY. IT IS THE DEALER'S RESPONSIBILITY TO ENSURE THAT THIS MAINTENANCE REQUIREMENT IS COMMUNICATED TO THE END USER AND FAILURE TO ADHERE TO MANUFACTURER MAINTENANCE REQUIREMENTS IS A FAILURE ON THE PART OF THE DEALER AND/OR END USER TO ADHERE TO THESE REQUIREMENTS. THERE IS NO PRODUCT DESIGN, MANUFACTURING, OR ASSEMBLY MALFUNCTION WHEN MAINTENANCE IS NOT ADHERED TO, IT IS A MAINTENANCE / USER MISUSE FAILURE. CONCLUSION: WHILE THIS IS BEING REPORTED AS A MALFUNCTION (ONE-ARM DRIVE WHEEL FALLING OFF) WITHOUT SERIOUS INJURY (BUT SERIOUS INJURY IS POSSIBLE, SHOULD THE INCIDENT RECUR), THIS IS A FAILING OF THE DEALER AND END USER TO PROPERLY MAINTAIN THEIR MEDICAL DEVICE TO ENSURE IT IS OPERATING, THROUGHOUT THE FIVE-YEAR LIFE SPAN OF THE PRODUCT, IN A SAFE AND EFFECTIVE MANNER. SUNRISE MEDICAL IS REPORTING THIS INCIDENT AS AN ADVERSE EVENT REPORT, HOWEVER, THERE ARE NO DESIGN, MANUFACTURING, OR ASSEMBLY ISSUES TO CORRECT. THEREFORE, THIS MATTER IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    USER CLAIMS THAT THE ONE-ARM DRIVE WHEEL FELL OFF OF HIS QUICKIE 2 WHEELCHAIR WHILE HE WAS SITTING IN THE CHAIR AND HE FELL TO THE FLOOR. HE CLAIMED THAT HE FELL ONTO HIS LEFT SIDE AND WAS "A LITTLE SORE" BUT DID NOT SEEK MEDICAL ATTENTION AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181653 QUICKIE Q2 MANUAL WHEELCHAIR IOR SUNRISE MEDICAL (US) LLC Q2

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other