BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRIC CHAIR

    MDR report key: 4190101 · Received October 15, 2014

    Report

    Report Number
    MW5038676
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    August 20, 2014
    Report Date
    October 15, 2014
    Manufacturer
    HOVEROUND
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    OVER TWO MONTHS AGO, I HAD A SEAT REPLACEMENT FOR MY HOVEROUND. I HAVE HAD PROBLEMS WITH THE SEAT NOT BEING ABLE TO FOLD DUE TO A FAULTY HANDLE FROM THE FIRST WEEK. I CALLED AND ASKED FOR A REPLACEMENT SEAT. THEY WOULD NOT DO IT AND SENT THE TECHNICIAN OUT 2 WEEKS LATER TO FIX IT. THE HANDLE STARTED FALLING OFF AND WOULD NOT STAY IN PLACE AND WORK AND IF THE HANDLE FALLS OUT AND GETS LOST, I CANNOT FOLD OR UNFOLD THE SEAT. ADDITIONALLY, I PLACED AN ORDER FOR A NEW SET OF TIRES FOR THE CHAIR, REPLACED THE SAME DAY AS THE SEAT. THEY PUT THE WRONG TYPE ON AND I CALLED. THEY ORDERED A NEW SET AND SENT THE TECH OUT TO REPLACE THEM, BUT THEY DID NOT SET THE APPOINTMENT WITH ME BEFORE THEY CAME OUT. WE HAD TO RESCHEDULE AND THEY SAID THE TECH WOULD BE OUT THE NEXT WEEK AND WOULD CALL ME TO CONFIRM. THE TECH DID NOT SHOW, SO I CALLED AND FOUND OUT THEY GAVE MY (PAID FOR) TIRES TO SOME ONE ELSE AND I WOULD HAVE TO WAIT FOR A NEW SET TO COME FROM THE WAREHOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652669 ELECTRIC CHAIR MOTORIZED WHEELCHAIR ITI HOVEROUND TEKNIQUE HD-6

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR