BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 6487418 · Received April 12, 2017

    Report

    Report Number
    9615350-2017-00002
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Report Date
    April 12, 2017
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    KNN
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OCCUPATIONAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST KNOWN INCIDENT REPORTED OF OUR INVACARE-MATRX MX1 BACK BECOMING DISENGAGED FROM THE WHEELCHAIR DUE TO THE LATCH HARDWARE NOT ENGAGING PROPERLY, AND THEREBY CAUSING THE END USER TO FALL BACKWARD FROM THE WHEELCHAIR. THE MX1 BACK HAS BEEN ON THE MARKET SINCE 2011. AT PRESENT, MOTION CONCEPTS IS NOT ABLE TO COMPLETE A THOROUGH INVESTIGATION, DUE TO A LACK OF INFORMATION PROVIDED FROM THE DEALER. MOTION CONCEPTS HAS REQUESTED, BUT TO DATE HAS NOT BEEN PROVIDED ANY IMAGES OF THE ALLEGED DEFECTIVE HARDWARE AND/OR ANY IMAGES TO SHOW HOW THE MX1 BACK WAS INSTALLED ON THE WHEELCHAIR. THE ALLEGED DEFECTIVE HARDWARE COMPONENTS ARE BEING RETURNED BY NUMOTION TO MOTION CONCEPTS FOR OUR INSPECTION/EVALUATION, BUT HAVE NOT BEEN RECEIVED AT THIS TIME. MOTION CONCEPTS' INVESTIGATION REMAINS OPEN, PENDING RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ON 13-MARCH 2017, MOTION CONCEPTS WAS NOTIFIED BY NUMOTION (DEALER) OF AN ALLEGED INCIDENT INVOLVING ONE OF OUR INVACARE-MATRX MX1 BACKS. NUMOTION WAS INFORMED BY THE END USER THAT HER MX1 BACK HAD BECOME DISENGAGED SUDDENLY FROM HER WHEELCHAIR CAUSING HER TO FALL BACKWARD AND BUMP HER HEAD. THE END USER DID NOT SEEK MEDICAL ATTENTION. THE DEALER ALLEGES THE LATCH MECHANISM ON THE HARDWARE WAS NOT ENGAGING PROPERLY CAUSING THE BACK TO BECOME DISENGAGE. THE ORIGINAL INVACARE MATRX MX1 BACK (MODEL: IMX11512-CR) WAS SOLD TO NUMOTION IN JUNE 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269422 POWERED WHEELCHAIR SYSTEM WHEELCHAIR KNN MOTION CONCEPTS LP INVA/MATRX MX1 BACK FITS W: 15", H: 12"

    Patients

    Seq Age Sex Outcome Treatment
    1 Other