BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDX SP POWER CHAIR

    MDR report key: 4020915 · Received August 14, 2014

    Report

    Report Number
    MW5037730
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Date of Event
    September 1, 2013
    Report Date
    August 14, 2014
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER A TORNADO ACCIDENT, PATIENT BECAME HANDICAPPED. HE BOUGHT THE INVACARE CDX SP POWER CHAIR IN (B)(6) 2013. IT WORKED WELL FOR A FEW MONTHS AND THEN STARTED MALFUNCTIONING BY SKIPPING AND ONCE RAN A PERSON OVER (BECAUSE PATIENT HAD LOST CONTROL OF THE DEVICE). AT ONE TIME, IT POWERED OFF AND WHEN ON REVERSE. PATIENT BELIEVES THAT CELLPHONE TOWERS INSTALLED IN HIS NEIGHBOURHOOD AS WELL AS A CONSTRUCTION SITE ARE CAUSING THE MALFUNCTION. THE JOYSTICK ON THE WHEELCHAIR IS PLASTIC. HE CLAIMS THE SHIELDING IS INSUFFICIENT. BASICALLY, HE SAYS THE DESIGN IS FLAWED. CONSEQUENTLY, HE'S BEEN WITHOUT A WHEELCHAIR FOR 6 MONTHS AND BELIEVES INVACARE IS RIPPING-OFF ITS CUSTOMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486306 TDX SP POWER CHAIR WHEELCHAIR ITI INVACARE

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR