BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE ECG SOFTWARE

    MDR report key: 6598602 · Received May 30, 2017

    Report

    Report Number
    1218950-2017-03631
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Report Date
    May 10, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQK
    PMA / PMN Number
    K120855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT QTC NUMBER IS SHOWING DIFFERENT THAN WHAT COMES OVER TO THE SERVER. THIS COMPLAINT HAS BEEN EVALUATED AND DOES NOT ALLEGE A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381076 INTELLISPACE ECG SOFTWARE PROGRAMMABLE DIAGNOSTIC COMPUTER DQK PHILIPS MEDICAL SYSTEMS 860426

    Patients

    Seq Age Sex Outcome Treatment
    1