BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 4712353 · Received April 21, 2015

    Report

    Report Number
    9615350-2015-00001
    Event Type
    Injury
    Date Received
    April 21, 2015
    Date of Event
    March 27, 2015
    Report Date
    April 21, 2015
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    ITI
    PMA / PMN Number
    K023426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, DEALER NAMED "(B)(6)" CONTACTED MOTION CONCEPTS TO REPAIR A WHEELCHAIR FOR THEIR CLIENT. (B)(6) NOTIFIED MOTION CONCEPTS THAT THE END USER DROPPED A LIT BUTANE LIGHTER ONTO HIMSELF/WHEELCHAIR SEAT, WHILE ATTEMPTING TO LIGHT A CIGARETTE. WE WERE ADVISED THAT THE MALE USER SUFFERED BURNS FROM THE RESULTING FIRE AND REQUIRED HOSPITALIZATION (NO FURTHER INFORMATION HAS BEEN PROVIDED DESPITE OUR REQUESTS). THE IDENTIFIED MOTION CONCEPTS POWER POSITIONING SYSTEM WAS INSTALLED ONTO A PRIDE MOBILITY (QUANTUM Q6 EDGE) WHEELCHAIR BASE. THE WHEELCHAIR SYSTEM WAS SOLD TO (B)(6) (DEALER); AT THE TIME OF THE ORDER, THERE WAS NO SEAT CUSHION ORDERED BY THE DEALER. THE ATTENDING DEALER HAS CONFIRMED THAT THE SEAT CUSHION INSTALLED ONTO THE WHEELCHAIR WAS MANUFACTURED BY THIRD PARTY (B)(4). THE FIRE DAMAGED WHEELCHAIR WAS RETURNED TO MOTION CONCEPTS FOR INSPECTION/EVALUATION ON (B)(4) 2015. THE ORIGINAL (B)(4) SEAT CUSHION WAS NOT RETURNED WITH THE WHEELCHAIR. BASED ON THE INCIDENT REPORT AND OUR SUBSEQUENT INVESTIGATION, IT APPEARS THAT THE SEAT CUSHION AND/OR THE USERS CLOTHING WERE THE LIKELY SOURCE OF IGNITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264646 POWERED WHEELCHAIR SYSTEM WHEELCHAIR ITI MOTION CONCEPTS LP TRX ULTRA LOW CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization