BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS HEMODYNAMIC APPLICATION

    MDR report key: 10724999 · Received October 23, 2020

    Report

    Report Number
    3003768277-2020-01015
    Event Type
    Death
    Date Received
    October 23, 2020
    Date of Event
    October 7, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    MWI
    PMA / PMN Number
    K181311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A DEATH HAS BEEN REPORTED TO PHILIPS, THAT OCCURRED DURING A PROCEDURE FOR WHICH THE PHILIPS HEMODYNAMICS SYSTEM WAS USED. PHILIPS HAS STARTED AND INVESTIGATION FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE CUSTOMER REPORTED TO PHILIPS SEVERAL ISSUES RELATED TO THE PHILIPS HEMODYNAMIC SYSTEM. PHILIPS HAS COMPLETED A GOOD FAITH EFFORT TO GET FURTHER INFORMATION ON THE REPORTED COMPLAINT. DURING THESE ATTEMPTS, THE CUSTOMER INDICATED THAT THE DEATH OF THE PATIENT WAS NOT A RESULT OF A MALFUNCTION OF THE SYSTEM. THE CUSTOMER HAS INDICATED THAT THEY WILL NOT BE PROVIDING ADDITIONAL INFORMATION. THE ISSUES REPORTED HAVE BEEN ANALYZED BY PHILIPS AND NO MALFUNCTION OF THE HEMODYNAMIC SYSTEM HAS BEEN IDENTIFIED. ALL ISSUES HAVE BEEN CONFIRMED TO BE POTENTIAL IMPROVEMENTS FOR THE HEMODYNAMIC SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193177 PHILIPS HEMODYNAMIC APPLICATION MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. PHILIPS HEMODYNAMIC APPLICATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death