BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 23060705 · Received September 16, 2025

    Report

    Report Number
    1218950-2025-000532
    Event Type
    Death
    Date Received
    September 16, 2025
    Date of Event
    August 22, 2025
    Report Date
    October 14, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838082236
    PMA / PMN Number
    K180017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ONSITE TO GATHER CLINICAL AUDIT LOGS FOR ANALYSIS. HE CONFIRMED THE CLINICAL STAFF WAS AWARE OF THE SOFT TECHNICAL INOP'S AND THAT THE DEVICE LOST CONNECTIVITY TO THE CENTRAL STATION. THE FSE ADVISED THAT THIS DISCONNECT COULD BE DUE TO THE DISTANCE FROM THE NEAREST NETWORK ACCESS POINT OR LOTS OF CONSTRUCTION/EXPANSION ON SITE. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION TO THE RESPONSIBLE PRODUCT SUPPORT ENGINEER (PSE). THE PSE CONFIRMED THE DATA ARE SHOWING ALARM/INOP SOUND SILENCING ON (B)(6) 2025 BETWEEN 1930 AND 1940. HE STATED FURTHER THAT THERE DOES NOT APPEAR TO BE AN SPO2 EVENT OCCURRING AT THE SPECIFIC TIMEFRAME REFERENCED ABOVE. THE NEAREST SPO2 EVENTS OCCURRED BETWEEN 19:40 AND 19:50. THE CLOSEST PREVIOUS EVENT OCCURRED AT 18:46. THE PSE FORWARDED THE LOG FOR FURTHER ANALYSIS TO THE CLINICAL SPECIALIST (CS). THE CS CONFIRMED THE FOLLOWING: THE LOG EXTRACT SHOWS MULTIPLE INOPS FOR SPO2 NO PULSE AT 18:18:22, 19:40:03, 19:44:40,19:45:29, 19:46:12, 19:46:43, 19:47:23, 19:48:15. (B)(6) 2025 18:18:24, (B)(6) HOSPITAL, 233, SPO2T NO PULSE GENERATED AT 18:18:22. T00023. (B)(6) 2025 19:40:05, (B)(6) HOSPITAL, 233, SECTOR: SPO2T NO PULSE GENERATED AT 19:40:03. PIC IX: TELE-SV3. (B)(6) 2025 19:44:44, (B)(6) HOSPITAL, 233, SECTOR: SPO2T NO PULSE GENERATED AT 19:44:40. PIC IX: TELE-SV3. (B)(6) 2025 19:45:33, (B)(6) HOSPITAL, 233, SECTOR: SPO2T NO PULSE GENERATED AT 19:45:29. PIC IX: TELE-SV3. (B)(6) 2025 19:46:16, (B)(6) HOSPITAL, 233, SECTOR: SPO2T NO PULSE GENERATED AT 19:46:12. PIC IX: TELE-SV3. (B)(6) 2025 19:46:47, (B)(6) HOSPITAL, 233, SECTOR: SPO2T NO PULSE GENERATED AT 19:46:43. PIC IX: TELE-SV3. (B)(6) 2025 19:47:27, (B)(6) HOSPITAL, 233, SPO2T NO PULSE GENERATED AT 19:47:23. T00023. (B)(6) 2025 19:48:19, (B)(6) HOSPITAL, 233, SPO2T NO PULSE GENERATED AT 19:48:15. T00023. THERE WAS A YELLOW PAUSE ALARM AT 19:44:24, **HR 45 < 50 ALARM AT 19:44:24 AND ***XBRADY 38 <40 AT 19:45:55 AND *** ASYSTOLE AT 19:46:45, AS WELL AN ACKNOWLEDGE ACTION FROM THE PIC IX AT 19:47:23. (B)(6) 2025 19:44:28, (B)(6) HOSPITAL, 233, SECTOR: * PAUSE, GENERATED AT 19:44:24. PIC IX: TELE-SV3. (B)(6) 2025 19:44:28, (B)(6) HOSPITAL, 233, SECTOR: **HR 45 <50, GENERATED AT 19:44:24. PIC IX: TELE-SV3. (B)(6) 2025 19:45:59, (B)(6) HOSPITAL, 233, SECTOR: ***XBRADY 38 <40, GENERATED AT 19:45:55. PIC IX: TELE-SV3. (B)(6) 2025 19:46:49, (B)(6) HOSPITAL, 233, SECTOR: *** ASYSTOLE, GENERATED AT 19:46:45. PIC IX: TELE-SV3. (B)(6) 2025 19:47:23, (B)(6) HOSPITAL, 233, ACKNOWLEDGE, PIC IX: TELE-SV3. THE MX40 WENT OFFLINE FROM 19:43:24 UNTIL 19:44:24. THE LOG DO NOT EXPLAIN THE REASON FOR THIS DISCONNECT. (B)(6) 2025 19:43:24, (B)(6) HOSPITAL, 233, EQUIPMENT OFFLINE, T00023. (B)(6) 2025 19:44:24, (B)(6) HOSPITAL, 233, EQUIPMENT ONLINE, T00023. THE OVERALL STATEMENT FROM THE CS WAS THAT THE NO PULSE INOPS WERE GENERATED ALONG WITH RED AND YELLOW ECG ALARMS AROUND THE TIME OF THE INCIDENT, AS WELL AS STAFF INTERACTION WITH THE PIC IX TO ACKNOWLEDGE THOSE ALARMS ARE DOCUMENTED IN THE LOGS. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS CONDUCTED, THE DEVICE WAS CONFIRMED TO BE OPERATING TO ITS SPECIFICATION WITH NO FAILURES FOUND. ANALYSIS WAS PERFORMED AND INVESTIGATION HAS BEEN COMPLETED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS, AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CUSTOMER REQUESTED ASSISTANCE OBTAINING THE LOGS FOR A TELEMETRY PATIENT AFTER THE PATIENT PASSED AWAY. THE CUSTOMER WANTED TO KNOW WHAT TECHNICAL ALARMS WERE ACKNOWLEDGED WHEN THERE WAS NO VISIBLE PULSE. BIOMED REVIEWED ALARMS AND WAS ABLE TO SEE TECHNICAL INOP ALARMS FOR WEAK SIGNAL AND NO PULSE, AS WELL AS ACKNOWLEDGMENTS AND ALARM PAUSES. THE UNIT DIRECTOR WAS ABLE TO FIND THE DETAILS NEEDED FOR THEIR INTERNAL INVESTIGATION FOR THE REPORTED TIME FRAME AT (B)(6) 2025 AROUND 19:40 ON BED 233. ESPECIALLY THE CUSTOMER WAS LOOKING FOR SPO2 ALARMS SILENCED STARTING AROUND 19:35. BASED ON A GOOD FAITH EFFORT ATTEMPT NEW INFORMATION WAS RECEIVED. THIS INFORMATION INDICATED THE PATIENT PASSED AWAY DUE TO CARDIAC ARREST/PULSELESS ELECTRICAL ACTIVITY. THE USERS WERE AWARE OF THE VISUAL TECHNICAL INOP GENERATED AT THE CENTRAL STATION BUT IT WAS REITERATED THE DEVICE LOST CONNECTIVITY AS IT WAS FREQUENTLY POWERED OFF AND ON. THE DEVICE WAS TAKEN OUT OF SERVICE. IT APPEARS THERE WAS NO DEVICE MALFUNCTION AS THE DEVICE WAS PROVIDING INOP ALARMS AND THE USERS WERE AWARE OF THE ALARMS; THEREFORE, IT ALSO APPEARS USER ERROR RELATED TO ALARM MANAGEMENT OR CLINICAL WORKFLOW MAY HAVE BEEN FACTORS IN THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CUSTOMER REQUESTED ASSISTANCE OBTAINING THE LOGS FOR A TELEMETRY PATIENT AFTER THE PATIENT PASSED AWAY. THE CUSTOMER WANTED TO KNOW WHAT TECHNICAL ALARMS WERE ACKNOWLEDGED WHEN THERE WAS NO VISIBLE PULSE. BIOMED REVIEWED ALARMS AND WAS ABLE TO SEE TECHNICAL INOP ALARMS FOR WEAK SIGNAL AND NO PULSE, AS WELL AS ACKNOWLEDGMENTS AND ALARM PAUSES. THE UNIT DIRECTOR WAS ABLE TO FIND THE DETAILS NEEDED FOR THEIR INTERNAL INVESTIGATION. BASED ON A GOOD FAITH EFFORT ATTEMPT NEW INFORMATION WAS RECEIVED. THIS INFORMATION INDICATED THE PATIENT PASSED AWAY DUE TO CARDIAC ARREST/PULSELESS ELECTRICAL ACTIVITY. THE USERS WERE AWARE OF THE VISUAL TECHNICAL INOP GENERATED AT THE CENTRAL STATION BUT IT WAS REITERATED THE DEVICE LOST CONNECTIVITY AS IT WAS FREQUENTLY POWERED OFF AND ON. THE DEVICE WAS TAKEN OUT OF SERVICE. IT APPEARS THERE WAS NO DEVICE MALFUNCTION AS THE DEVICE WAS PROVIDING INOP ALARMS AND THE USERS WERE AWARE OF THE ALARMS; THEREFORE, IT ALSO APPEARS USER ERROR RELATED TO ALARM MANAGEMENT OR CLINICAL WORKFLOW MAY HAVE BEEN FACTORS IN THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295178 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING MHX PHILIPS MEDICAL SYSTEMS MX40 1.4 GHZ SMART HOPPING 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death