BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRONTO M61

    MDR report key: 4381560 · Received January 5, 2015

    Report

    Report Number
    1525712-2014-08369
    Event Type
    Malfunction
    Date Received
    January 5, 2015
    Report Date
    November 10, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY DEALER THAT BOTH MOTOR AND GEARBOXES ON THE M61 POWER CHAIR ARE GETTING HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3731 PRONTO M61 WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET M61

    Patients

    Seq Age Sex Outcome Treatment
    1 Other