BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC XOMED

    MDR report key: 433819 · Received December 16, 2002

    Report

    Report Number
    MW1027012
    Event Type
    Malfunction
    Date Received
    December 16, 2002
    Report Date
    December 16, 2002
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    METAL HAND PIECE IS CONNECTED DIRECTED DIRECTLY TO EARTH GROUND CREATING A CURRENT SINK SOURCE FROM PT TO GROUND. UNIT IS A TYPE B -IEC 601- WHICH SHOULD BE A TYPE BF FOR PT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC XOMED DRILL SYSTEM ERL MEDTRONIC XOMED INC. XPS-3000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other