BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MX40 802.11A/B/G

    MDR report key: 21480052 · Received February 27, 2025

    Report

    Report Number
    1218950-2025-000130
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    January 30, 2025
    Report Date
    April 29, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    UDI-DI
    00884838030350
    PMA / PMN Number
    K113125
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION, AND THE PHILIPS PRODUCT SUPPORT ENGINEER (PSE) SEARCHED THE LOGS AND DETERMINED THAT A LOW BATTERY INOP WAS LOGGED AT 23:56:59.546 ON (B)(6) 2025. THE MX40 WAS POWERED ON AT 13:41:02.447 ON (B)(6) 2025. THE MX40 CONNECTED TO THE SYSTEM WITH BELOW BATTERY LEVEL (3.939V) AND LOST CONNECTION TO THE CENTRAL AT 23:18:28.047 ON (B)(6) 2025. SEE EXCERPT OF LOGS BELOW: 13:45:29.256 (B)(6) 2025: RFASSOCMGR - SENDING ASSOCIATION MESSAGE TO LBN(2), EQUIPLABEL(TM1.C2S), BEDLABEL(T1.C2S), IP(10.17.17.7), MAC(0009FBA575D7). 13:45:30.004 (B)(6) 2025: RFASSOCMGR - RECEIVED ASSOCIATION RESPONSE FROM DEVICE LBN(2) MONITOR(TM1.C2S) -> DEVICE ASSOCIATED. 13:45:30.471 (B)(6) 2025: TM1.C2S FEATURE VECTOR 0: DEVICE SENDS SERVERFEATURES 0XEA000000, CLIENTFEATURES 0XA0000002. PIC IX SETS FINAL SERVERFEATURES 0XEA000000, CLIENTFEATURES 0XA0000003 13:45:30.471 (B)(6) 2025: TM1.C2S FEATURE VECTOR 1: DEVICE SENDS SERVERFEATURES 0X9933CC80, CLIENTFEATURES 0XC0000000. PIC IX SETS FINAL SERVERFEATURES 0X9933CC80, CLIENTFEATURES 0XC0000000 13:45:31.244 (B)(6) 2025: RFASSOCMGR - DEVICE WITH LBN(2) MONITOR(TM1.C2S) ENTERING MONITORING STATE. 13:45:31.244 (B)(6) 2025: TM1.C2S: DISCONNINFO: REBOOT, 3939. 13:45:33.780 (B)(6) 2025: TM1.C2S: ECG ENABLE - USING ECG CABLE. A NEW BATTERY WAS INSERTED AT 23:23:58.988 ON (B)(6) 2025. THE MONITOR RESTARTED AND CONNECTED TO THE SYSTEM WITH NEW BATTERY LEVEL (4.049V). THE HIGHER BATTERY LEVEL INDICATES THAT A DIFFERENT BATTERY WAS INSERTED. IF THE MONITOR WOULD HAVE DISCONNECTED FOR A TECHNICAL PROBLEM, WE WOULD TYPICALLY FIND A LOG ENTRY REGARDING A LOW COVERAGE MESSAGE POINTING TO A LOSS OF CONNECTIVITY. SINCE WE DO NOT FIND SUCH ENTRY BETWEEN 23:18:28.047 AND 23:23:58.988 ON (B)(6) 2025, THE MONITOR MUST HAVE BEEN INTENTIONALLY TURNED OFF AND THE BATTERY REMOVED. SEE EXCERPT OF LOGS BELOW: 23:18:28.047 (B)(6) 2025: RFASSOCMGR - DEVICE WITH LBN(2) MONITOR(TM1.C2S) TIMED OUT DURING MONITORING STAGE -> ABORTING DEVICE... 23:18:28.047 (B)(6) 2025: RFASSOCMGR - CENTRAL SENDING ABORT MESSAGE TO LBN(2) MONITOR(TM1.C2S). 23:23:58.988 (B)(6) 2025: RFASSOCMGR - SENDING ASSOCIATION MESSAGE TO LBN(2), EQUIPLABEL(TM1.C2S), BEDLABEL(T1.C2S), IP(10.17.17.7), MAC(0009FBA575D7). 23:23:59.660 (B)(6) 2025: RFASSOCMGR - RECEIVED ASSOCIATION RESPONSE FROM DEVICE LBN(2) MONITOR(TM1.C2S) -> DEVICE ASSOCIATED. 23:24:00.168 (B)(6) 2025: TM1.C2S FEATURE VECTOR 0: DEVICE SENDS SERVERFEATURES 0XEA000000, CLIENTFEATURES 0XA0000002. PIC IX SETS FINAL SERVERFEATURES 0XEA000000, CLIENTFEATURES 0XA0000003 23:24:00.168 (B)(6) 2025: TM1.C2S FEATURE VECTOR 1: DEVICE SENDS SERVERFEATURES 0X9933CC80, CLIENTFEATURES 0XC0000000. PIC IX SETS FINAL SERVERFEATURES 0X9933CC80, CLIENTFEATURES 0XC0000000 23:24:01.437 (B)(6) 2025: RFASSOCMGR - DEVICE WITH LBN(2) MONITOR(TM1.C2S) ENTERING MONITORING STATE. 23:24:01.437 (B)(6) 2025: TM1.C2S: DISCONNINFO: REBOOT, 4049. 23:24:04.039 (B)(6) 2025: TM1.C2S: ECG ENABLE - USING ECG CABLE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE DEVICE WAS FUNCTIONING AS INTENDED. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER'S SITE. THE FSE REPORTED THE CUSTOMER WAS USING AN OLD BATTERY FROM 2020. THE SETTINGS ON THE CONTROL PANEL WERE CHECKED WITH THE SUPPORT OF THE APPLICATION AND ALL ALARMS WERE CONFIGURED CORRECTLY. THE MX40 WAS UPDATED TO SOFTWARE VERSION C.03.03, AND THE CONFIGURATION HAS BEEN RELOADED. IN ADDITION, THE NETWORK DATA WAS PASSED ON TO THE IT DEPARTMENT IN ORDER TO BE ABLE TO RULE OUT PROBLEMS WITH THE WLAN. THE SYSTEMS WERE PROPERLY HANDED OVER TO THE CUSTOMER. 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. SECTION E REPORTING INSTITUTION PHONE #:(B)(6). SECTION E REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE INTELLIVUE MX40 802.11A/B/G INDICATING THAT ON (B)(6) 2025, THE MX40 (BED LABEL TM1.C2S) DID NOT SOUND THE ALARM DURING THE NIGHT WHEN THE BATTERY RAN OUT. THE CUSTOMER DID NOT PROVIDE A CLEAR TIME ON WHEN THE ISSUE OCCURRED. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MX40 DOES NOT ALARM WHEN THE BATTERY WAS LOW. 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
    1030856 INTELLIVUE MX40 802.11A/B/G INTELLIVUE MX40 802.11A/B/G DSI PHILIPS MEDICAL SYSTEMS 865352 00884838030350

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown