BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2923505 · Received January 22, 2013

    Report

    Report Number
    1525712-2013-00432
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 16, 2013
    Manufacturer
    UNKNOWN
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. DEALER STATES THE RIGHT MOTOR IS LEAKING OIL. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30113 POWERED WHEELCHAIR 890.3860 ITI UNKNOWN M51

    Patients

    Seq Age Sex Outcome Treatment
    1 Other