BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3013913 · Received March 20, 2013

    Report

    Report Number
    1525712-2013-02134
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    PROVIDER STATES THAT STEALTH ADDUCTOR IS DEFECTIVE AND NEEDS A REPLACEMENT. (P/N 1164877).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115888 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other