BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

    MDR report key: 16371638 · Received February 14, 2023

    Report

    Report Number
    16371638
    Event Type
    No answer provided
    Date Received
    February 14, 2023
    Date of Event
    January 15, 2023
    Report Date
    January 25, 2023
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WE EXPERIENCED A POWER OUTAGE WHICH LED TO A PHILLIPS MONITOR ISSUE. NURSING CAN VIEW RHYTHMS AND VITAL SIGNS FROM THE CENTRAL MONITOR, BUT MONITORS ARE NOT COMMUNICATING WITH EPIC. UPDATE FROM UF: WE FOUND OUT FROM PHILIPS THAT THE ISSUE WAS WITH A SERVICE/PROCESS ON THE SERVER STOPPING INTERMITTENTLY AND RESTARTING WHICH TAKES ABOUT 5 SECONDS TO REACH FUNCTIONAL STATE. THE SERVICE STOPPING ISSUE HAPPENS WHEN HIGH LOG ON/LOG/OFF ACTIVITY OCCURS VIA THE CARE ASSIST APP POSSIBLY AT SHIFT CHANGES. PHILIPS REPORTED THAT THEY HAD KNOWN ABOUT THIS ISSUE AS EARLY AS JULY 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648560 MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS NORTH AMERICA LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown