BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECG SYSTEMS

    MDR report key: 556430 · Received May 3, 2004

    Report

    Report Number
    8043485-2003-00004
    Event Type
    Malfunction
    Date Received
    May 3, 2004
    Report Date
    December 28, 2003
    Manufacturer
    ESAOTE, S.P.A.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION WAS REPORTED TO ESAOTE BY SERVICE PERSONNEL; IF CERTAIN KEYS ARE PRESSED DURING REST ECG PROCEDURE, ECG DATA MAY BE ASSIGNED TO THE WRONG PT; NO REPORT OF INJURIES ASSOCIATED WITH THIS MALFUNCTION HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECG SYSTEMS ECG SYSTEMS DRT ESAOTE, S.P.A. 9704210000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *