BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 18084356 · Received November 7, 2023

    Report

    Report Number
    1218950-2023-00845
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    October 17, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS A CRITICAL COMMUNICATION BREAKDOWN BETWEEN THE CENTRAL MONITORING STATIONS ON THE NTH PRIMARY AND THE SERVER. PHILIPS IS ALSO VERIFYING THE STATUS OF THE EST PRIMARY SERVER TO CONFIRM THE ISSUE. DURING THIS TIME FRAME, ALL HOSTS LOCATED OUTSIDE OF THE DATA CENTER EXPERIENCED AN INABILITY TO ESTABLISH COMMUNICATION WITH THE PRIMARY SERVER. WHILE THE PHYSIO MONITORS COULD STILL CONNECT TO THE PRIMARY SERVER, NONE OF THE SURVEILLANCE AND OVERVIEW STATIONS HAD THIS CAPABILITY. THE PROBLEM APPEARED TO IMPACT ALL NORTH SITES WITHIN THE NETWORK. LOGS WERE PULLED AND REVIEWED BY THE FIELD SERVICE ENGINEER (FSE). WHILE LOOKING AT THE LOGS, IT WAS DETERMINED THAT THE ROOT CAUSE OF THE NETWORK COMMUNICATION BREAKDOWN WAS DUE TO THE CUSTOMER NETWORK CONNECTIVITY ACROSS THEIR WAN LINKS. PER RESOLUTION, THE CUSTOMER WAS PROVIDED WITH THE EVIDENCE OF THE OUTCOME OF THE FINDINGS. HOWEVER, THE TECHNICAL CONSULTANT (TC) TO PROVIDE THE NATIONAL SUPPORT SPECIALIST (NSS) WITH THE FOCALPOINT LOGS TO RUN THROUGH SOFTWARE AND INVESTIGATE THE PAST WEEKS OF OUTAGES. NSS INVOLVED IN CHECKING DROPS OR SCANNING ERRORS. THE ENGINEER PROVIDED THEIR ANALYSIS FINDINGS, AND IT WAS CONCLUDED THAT THE CAUSE OF THE COMMUNICATION BREAKDOWN ISSUE MAY BE DUE TO THE CUSTOMER NETWORK. FURTHER INVESTIGATION IS BEEN DONE BY THE NSS. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN PROCESS OF OBTAINING ADDITIONAL INFORMATION. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT NTH PRIMARY CENTRALS DROPPED. DURING THIS TIME FRAME, ALL HOSTS LOCATED OUTSIDE OF THE DATA CENTER EXPERIENCED AN INABILITY TO ESTABLISH COMMUNICATION WITH THE PRIMARY SERVER. WHILE THE PHYSIO MONITORS COULD STILL CONNECT TO THE PRIMARY SERVER, NONE OF THE SURVEILLANCE AND OVERVIEW STATIONS HAD THIS CAPABILITY. THE PROBLEM APPEARED TO IMPACT ALL NORTH SITES WITHIN OUR NETWORK.WHILE PHILIPS DEVICES PROVIDE MITIGATIONS RELATED TO THE LOSS OF CENTRALIZED WIRELESS MONITORING (IE ¿NO CENTRAL MON¿ INOP, VISUAL AND AUDIBLE TONES, LOCAL MONITORING FOR MX40), A MALFUNCTION THAT LEADS TO THE LOSS OF MONITORING FOR NUMEROUS PATIENTS USING MIXED WIRELESS DEVICES MAY RESULT IN A DELAYED RESPONSE TO AN INDIVIDUAL PATIENT REQUIRING EMERGENT CARE. THE DEVICE WAS IN USE.THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338558 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown