BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI

    MDR report key: 5418708 · Received February 9, 2016

    Report

    Report Number
    1525712-2016-00452
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Report Date
    January 25, 2016
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE DEALER STATED THAT THE END USER WAS COMPLAINING OF A NOISE COMING FROM THE RIMS OF THE CHAIR THE DEALER TOOK THE WHEELS OFF OF THE CHAIR AND NOTICED THAT THE RIM WAS WORN AND KEPT SLIDING UP AND DOWN ON THE CHAIR. STATED THAT THE PLASTIC RIMS WERE GOING UP AND DOWN AND HE WAS SWITCHING TO ALUMINUM ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79493 POWER CHAIR 20 WIDE BY 18 DEEP FOR PMI WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET R51LXP

    Patients

    Seq Age Sex Outcome Treatment
    1