BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2883299 · Received December 21, 2012

    Report

    Report Number
    1525712-2012-03201
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    December 20, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER CALLED STATING THAT A BURNT SMELL FROM CHAIR PER HER TECH. (B)(6) TO CHECK BACK WITH TECH SINCE UNSURE EXACTLY. MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 Other