BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM Q6 EDGE WITH TB3 POWER SEATING SYSTEM

    MDR report key: 5100572 · Received September 24, 2015

    Report

    Report Number
    5100572
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    July 15, 2015
    Report Date
    August 25, 2015
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORP
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTED HEARING "SOME NOISE" WHILE UTILIZING THE WHEELCHAIR THAT DAY. AT THE END OF THE DAY AFTER THE PATIENT WAS TRANSFERRED OUT OF THE CHAIR AND STORED IN THE ROOM FOR CHARGING, THEY HEARD A LOUD NOISE AND UPON CHECKING THE ROOM WITH THE CHAIR THE BACK REST UPPER SYSTEM HAD FALLEN OFF. NO INJURY(S). THE PATIENT HAS A BACKUP CHAIR. THE MANUFACTURER IS REPLACING THE ENTIRE CHAIR AND SEATING AT NO COST. MANUFACTURER RESPONSE FOR WHEELCHAIR, QUANTUM Q6 EDGE WITH TB3 POWER SEATING SYSTEM (PER SITE REPORTER): WORKING WITH THE MANUFACTURER ON RESOLUTION AND ACTION PLAN FOR THIS AND ALL OTHER CHAIRS WE HAVE DISTRIBUTED. THE PERMANENT FIX WILL BE REPLACING ALL RAILS PROVIDED BETWEEN A FIFTEEN MONTH PERIOD WITH THE NEW DESIGNED RAIL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632348 QUANTUM Q6 EDGE WITH TB3 POWER SEATING SYSTEM WHEELCHAIR, POWERED IOR PRIDE MOBILITY PRODUCTS CORP Q6 EDGE

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR NO