BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4221376 · Received November 3, 2014

    Report

    Report Number
    3008262382-2014-01822
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 15, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES THE BEARING BROKE ON THE PIN THAT RELEASE THE FOOTBOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701154 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M41SR20B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other