BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21976406 · Received May 7, 2025

    Report

    Report Number
    1218950-2025-000284
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 10, 2025
    Report Date
    June 27, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A PHILIPS FIELD SUPPORT ENGINEER (FSE) VISITED THE CUSTOMER SITE TO EVALUATE THE REPORTED ISSUE. THE FSE FOUND THE CUSTOMER INFORMATION TECHNOLOGY (IT) DEPARTMENT MADE ADJUSTMENTS OF WIFI CHANNELS TO USE ONLY 1 OR 1 5 7. THE SYSTEM IS CONFIGURED IN ADVANCED MODE TO USE ONLY THE LAST 6 SLOTS OF THE WIFI BAND SO AS NOT TO INTERFERE WITH THE ESTABLISHMENT'S WIFI. THE DISCONNECTIONS HAVE DECREASED BUT THE COVERAGE AREA VALIDATION (CAV) CARRIED OUT AFTER MODIFICATION DOES NOT ALLOW THE NETWORK COVERAGE TO BE VALIDATED AS IT IS. JOINT INTERVENTION WITH THE CUSTOMERS IT DEPARTMENT FOUND THAT IT SEEMS THAT THE ESTABLISHMENT'S WI-FI IS USING TOO MANY CHANNELS AND THAT THE INTELLIVUE TELEMETRY SYSTEM (ITS) IS HAVING DIFFICULTY FINDING ITS PLACE. A FOLLOW UP INTERVENTION IS PLANNED WITH THE CUSTOMER FOR (B)(6). REPORTING INSTITUTION PHONE # (B)(6). REPORTER PHONE # (B)(6).

    Additional Manufacturer Narrative · 0

    A PHILIPS FSE VISITED THE CUSTOMER SITE TO EVALUATE THE REPORTED ISSUE. THE FSE FOUND THE CUSTOMER INFORMATION TECHNOLOGY (IT) DEPARTMENT MADE ADJUSTMENTS OF WIFI CHANNELS TO USE ONLY 1 OR 1 5 7. THE SYSTEM IS CONFIGURED IN ADVANCED MODE TO USE ONLY THE LAST 6 SLOTS OF THE WIFI BAND SO AS NOT TO INTERFERE WITH THE ESTABLISHMENT'S WIFI. THE DISCONNECTIONS HAVE DECREASED BUT THE COVERAGE AREA VALIDATION (CAV) CARRIED OUT AFTER MODIFICATION DOES NOT ALLOW THE NETWORK COVERAGE TO BE VALIDATED AS IT IS. JOINT INTERVENTION WITH THE CUSTOMERS IT DEPARTMENT FOUND THAT IT SEEMS THAT THE ESTABLISHMENT'S WI-FI IS USING TOO MANY CHANNELS AND THAT THE INTELLIVUE TELEMETRY SYSTEM (ITS) IS HAVING DIFFICULTY FINDING ITS PLACE. IT WAS RECENTLY LEARNED THAT TELEVISIONS HAD BEEN INSTALLED WITH A BLUETOOTH HEADSET SYSTEM, AND WE BELIEVE THIS MAY BE THE CAUSE. SPECTRUM ANALYSIS CARRIED OUT IN THE USIC DEPARTMENT. IT WAS IDENTIFIED THAT THE SIGNAL IS SIGNIFICANTLY IMPROVED WHEN THE TV/HEADPHONE SYSTEM IS DISCONNECTED. WE THEREFORE RECOMMEND THAT THE CUSTOMER CONTACT ITS TV PROVIDER SO THAT IT CAN ADAPT ITS BROADCASTS TO SPECIFIC CHANNELS SO AS NOT TO FLOOD THE 2.4 GHZ RANGE AS IS CURRENTLY THE CASE. THE ITS SYSTEM IS CURRENTLY SET TO OPERATE BETWEEN CHANNELS 13 AND 14, THE ESTABLISHMENT'S WIFI IS LOCKED TO CHANNEL 1 ON THIS FLOOR. SOME RESIDUE FROM THE LOWER FLOOR IS DETECTED ON CHANNELS 7 AND 11 BUT DOES NOT INTERFERE WITH THE ITS. TESTS CARRIED OUT ACCORDING TO PHILIPS PROTOCOL ON THE CENTRAL STATION. IT WAS CONFIRMED THAT THERE IS NO FAILURE OF THE PHILIPS DEVICE, THIS IS RELATED TO THE CUSTOMERS NETWORK. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER IS EXPERIENCING A LOSS OF TELEMETRY CONNECTION WITH THE PIC IX. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470079 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown