BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 4679908 · Received April 10, 2015

    Report

    Report Number
    1525712-2015-02357
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    March 13, 2015
    Report Date
    March 13, 2015
    Manufacturer
    INVACARE REA AB
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AZALEA IS THE SAME /SIMILAR TO PRODUCTS WHICH ARE MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THE ALLEGED INCIDENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    "I HAVE RECEIVED AN ERROR REPORT ON A WHEELCHAIR AZALEA TALL, 44 WIDE SERIES NO: (B)(4), BOUGHT IN 2013-11-26. IT TURNS OUT THAT THERE IS NO SPACER WHERE THE USER BRAKE IS ATTACHED TO THE FRAME SO THE BRAKE TOUCHE ONLY A QUARTER OF THE SURFACE OF THE TIRE (THE RIGHT SIDE). THIS IS NOT SOMETHING THAT THEY REACTED TO EARLIER WHEN THEY USED THE ATTENDANT BRAKE A LOT, BUT NOW IT HAS BECOME A PROBLEM. LEFT BRAKE IS ALSO VERY POOR AND "FLABBY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242893 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVACARE REA AB AZALEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other