BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZY 600

    MDR report key: 12566453 · Received October 2, 2021

    Report

    Report Number
    9616084-2021-00058
    Event Type
    Malfunction
    Date Received
    October 2, 2021
    Date of Event
    September 1, 2021
    Report Date
    October 2, 2021
    Product Code
    IOR
    PMA / PMN Number
    K974820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BACKGROUND INFORMATION: THE AXEL BOLT DISCUSSED IN THE COMPLAINANT'S CLAIM ARE MOST LIKELY THE THREADED AXEL, PART NUMBER 920108. THE MAXIMUM WEIGHT LIMIT FOR THIS MODEL WHEELCHAIR IS 250 POUNDS (113 KG) AND THE END USER IS APPROXIMATELY (B)(6), THEREFORE, HER WEIGHT LIMIT IS WELL WITHIN THE WEIGHT CAPACITY OF THIS MODEL WHEELCHAIR. THE INCIDENT DESCRIBES AN INDOOR ENVIRONMENT WITH HARDWOOD FLOORS. NO OBSTACLES OR OBSTRUCTIONS PRECEDING THE AXEL BREAK WAS DESCRIBED AT THE TIME OF THE INCIDENT. GL501F8, REV. B, TABLE OF HARMS AND SEVERITIES, TABLE 1, DESCRIBES A FALL FROM A MANUAL WHEELCHAIR AS A POTENTIAL FOR MINOR INJURY (SPRAINS / JAMS GRADE 1; PAIN MODERATE; BRUISES; CUTS, LACERATIONS, GASHES AND TEARS NOT REQUIRING STITCHES). DISCUSSION: NO DESCRIPTION OF FORESEEABLE MISUSE OR ENVIRONMENTAL CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE AXEL BREAKAGE ARE DESCRIBED. CONCLUSION: THE AXEL BREAKAGE IS A MALFUNCTION OF MATERIALS AS THE WHEELCHAIR AGE, AT THE TIME OF BREAKAGE WAS 11 MONTHS. NO SERIOUS INJURY WAS CLAIMED. SHOULD THE MALFUNCTION RECUR, A POTENTIAL FOR SERIOUS INJURY IS HIGHLY UNLIKELY. TYPICALLY, THIS COMPLAINT WOULD NOT BE FILED AS AN ADVERSE EVENT; HOWEVER, DUE TO LEGAL CLAIMS, THIS CLAIM IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE END USER CLAIMS THAT ON (B)(6) 2021: WHILE SITTING STATIONARY, THE AXEL BOLT COMPLETELY SNAPPED ON THE RIGHT LARGE WHEEL. THE END USER CLAIMS THAT THE CHAIR COLLAPSED ON THE HARDWOOD FLOOR, WITH HER LANDING ON THE BROKEN WHEEL. THE END USER AND HER HUSBAND CALLED 911 AND THE EMS WORKERS CAME AND LIFTED HER ONTO THE BED. SHE NOW CLAIMS TO BE VERY SORE, SHAKY, AND EXTREMELY CONCERNED ABOUT THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464113 BREEZY 600 MANUAL WHEELCHAIR IOR BREEZY 600

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other