BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKIE 300M

    MDR report key: 22801649 · Received August 14, 2025

    Report

    Report Number
    2937137-2025-00001
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    May 1, 2024
    Report Date
    August 13, 2025
    Manufacturer
    SUNRISE MEDICAL (US) LLC
    Product Code
    ITI
    UDI-DI
    00016958060485
    PMA / PMN Number
    K142457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BACKGROUND INFORMATION QUICKIE Q300 M USERS ARE PROVIDED WITH THE Q300 OWNER MANUAL (ID # 253033) AS WELL AS THE APPLICABLE SEATING SYSTEM MANUAL. THE SEDEO LITE SEATING SYSTEM MANUAL (ID # 252852) INCLUDES THE FOLLOWING INSTRUCTIONS AND WARNINGS FOR THE POTENTIAL USE ERRORS REFERENCED ABOVE. THESE INCLUDE BUT ARE NOT LIMITED TO: (SECTION 4.5) DANGER/WARNING! 1. THE POSITIONING BELT IS PREDOMINANTLY 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. THE POSITIONING BELT IS NOT A TRANSIT RATED SAFETY BELT AND SHOULD NOT BE USED IN PLACE OF A SEAT BELT WHILE BEING TRANSPORTED IN A MOTOR VEHICLE. IMPROPER USE OF POSITIONING BELTS MAY CAUSE SEVERE INJURY OR DEATH. (SECTION 5.13) DANGER/WARNING! 1. ALWAYS ENSURE THAT THE LAP BELT IS CORRECTLY SECURED AND ADJUSTED PRIOR TO USE. 2. TOO LOOSE A BELT COULD CAUSE THE USER TO SLIP DOWN AND CAUSE SERIOUS INJURY. 3. CHECK LAP BELT AND SECURING COMPONENTS AT REGULAR INTERVALS FOR ANY SIGNS OF FRAY OR DAMAGE. REPLACE IF NECESSARY. (SECTION 6.1) DANGER/WARNING! 9. DO NOT STAND ON THE FOOTREST. PUTTING YOUR FULL WEIGHT ON THE FOOTREST MAY LEAD TO WHEELCHAIR DAMAGE AND TO HAZARDOUS SITUATIONS, INCLUDING THE WHEELCHAIR TIPPING UP. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE CHAIR (S/N # (B)(6)) AND THE CHAIR WAS DETERMINED TO HAVE BEEN ASSEMBLED AND TESTED ACCORDING TO THE ORDER FROM THE DEALER AND MANUFACTURER'S SPECIFICATIONS FOR THIS MODEL. THIS INCIDENT WAS STATED TO HAVE OCCURRED IN (B)(6) 2024 AND SUNRISE MEDICAL WAS NOT NOTIFIED UNTIL (B)(6) 2025. THIS COMPLAINT WILL BE UPDATED IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED AFTER THIS COMPLAINT IS REPORTED AND FILED AS AN MDR. CONCLUSION THE END USER SUSTAINED INJURIES WHILE USING A Q300M WHEELCHAIR. THERE IS NOT SUFFICIENT INFORMATION AT THE TIME OF THIS MDR REPORT TO CONCLUDE THIS WAS A MALFUNCTION OF THE DEVICE. IT IS TO BE NOTED THAT THE WARNINGS PROVIDED IN THE OWNER'S MANUAL ARE ASSOCIATED WITH KNOWNS RISKS AND THE RECOMMENDATIONS FOR USE SHOULD BE FOLLOWED TO BE BEST OF THE USER'S ABILITY. LAP BELTS SHOULD BE WORN WHILE USING THE DEVICE. APPLYING FULL WEIGHT TO THE FOOTPLATES COULD POTENTIALLY CAUSE TIPPING. THE CHAIR HAS NOT YET BEEN INSPECTED AS OF THE FILING OF THIS REPORT. IT IS UNKNOWN IF THE DEVICE WILL BE AVAILABLE FOR INSPECTION UPON REQUEST. THIS COMPLAINT IS BEING FILED AS AN MDR DUE TO THE INJURIES SUSTAINED BY THE END USER.

    Description of Event or Problem · 0

    SUMMONS WAS RECEIVED BY SUNRISE MEDICAL ON (B)(6) 2025 OF AN INJURY TO A 69 YEAR OLD END USER THAT TOOK PLACE IN EARLY (B)(6) 2024 (NO EXACT DATE OF INJURY WAS GIVEN, (B)(6) IS BEING USED AS EARLIEST POSSIBLE DATE). ACCORDING TO THE DETAILS PROVIDED IN THE SUMMONS, THE END USER ATTEMPTED TO SIT FORWARD SLIGHTLY TO READ A DOCUMENT, AND THE USER'S FOOT SLIPPED OFF THE FOOTPLATE, SHE BECAME UNSTABLE AND FELL FORWARD OUT OF THE WHEELCHAIR. IT WAS REPORTED THAT THE END USER SUSTAINED AN INJURY TO THE FEMUR. THIS INCIDENT IS STATED TO HAVE OCCURRED WITHIN HOURS AFTER THE DEALER'S TECHNICIAN MADE ADJUSTMENTS TO THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627335 QUICKIE 300M WHEELCHAIR,POWER ITI SUNRISE MEDICAL (US) LLC QUICKIE 300M 00016958060485

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other