BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2843566 · Received September 28, 2012

    Report

    Report Number
    2843566
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 28, 2012
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE EKG MONITORING BRICK (MODULE) WAS TRIED IN TWO DIFFERENT MONITORS AND WILL READ FOR A FEW MINUTES THEN GO BLACK. IT WOULD SOMETIMES COME BACK ON AND THEN AT OTHER TIMES WON'T SHOW UP ON THE MONITOR AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MONITOR, PHYSIOLOGICAL, MODULE MHX PHILIPS HEALTHCARE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *