BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS HEMODYNAMIC APPLICATION

    MDR report key: 10153445 · Received June 15, 2020

    Report

    Report Number
    3003768277-2020-00034
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Report Date
    May 18, 2020
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MWI
    UDI-DI
    00884838084544
    PMA / PMN Number
    K181311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. PHILIPS HAS CONFIRMED THAT WHEN THE CONNECTION WAS LOST TO THE PHILIPS HEMODYNAMICS APPLICATION, THE PATIENT WAS UNDER LOCAL ANESTHESIA AND THE CATHETER HAD ALREADY BEEN PLACED. THE SYSTEM AUTOMATICALLY RESUMED CONNECTION AFTER 45 SECONDS, AFTER WHICH THE PROCEDURE WAS CONTINUED TO COMPLETION. PHILIPS HAS CONFIRMED WITH THE CUSTOMER THAT NO HARM HAS OCCURRED TO THE PATIENT. THE ANALYSIS OF THE LOG FILES CONFIRMED THE LOSS OF CONNECTION BETWEEN THE PHILIPS HEMODYNAMICS PC AND THE PHILIPS XPER IXR FLEX CARDIO 2010. PHILIPS HAS INSPECTED THE SYSTEM ON SITE AND IDENTIFIED A FAULTY NETWORK CABLE BETWEEN THE HEMODYNAMICS PC AND THE XPER IXR FLEX CARDIO 2010. THE NETWORK CABLE WAS REPLACED AFTER WHICH THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. BASED ON THE INVESTIGATION RESULTS, PHILIPS HAS CONCLUDED THAT THE LOSS OF HEMODYNAMIC MONITORING WAS MOST LIKELY CAUSED BY A FAULTY NETWORK CABLE. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING A CORONARY ANGIOGRAPHY (CAG), VISUALS OF ALL HEMODYNAMICS APPLICATION READINGS WERE LOST FOR A WHILE DURING THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620023 PHILIPS HEMODYNAMIC APPLICATION MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) MWI PHILIPS HEALTHCARE 002010 1.1.0.0 00884838084544

    Patients

    Seq Age Sex Outcome Treatment
    1