BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX40 WLAN

    MDR report key: 17210137 · Received June 27, 2023

    Report

    Report Number
    1218950-2023-00442
    Event Type
    Death
    Date Received
    June 27, 2023
    Date of Event
    May 20, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    UDI-DI
    00884838030350
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BIOMEDICAL TECHNICIANS AND HOSPITAL STAFF PERFORMED TESTING ON THE MX40 AND PIC IX C ST EFP DEVICES INCLUDING CONNECTIVITY AND RAN SEVERAL SUCCESSFUL ALARM TESTS. THE BIOMEDICAL TECHNICIANS AND HOSPITAL STAFF CONCLUDED THAT THE PIC IX C ST EFP DEVICE WAS WORKING CORRECTLY. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION TO A PHILIPS PRODUCT SUPPORT ENGINEER (PSE). WAVE STRIPS, DEVICE LOG FILES, AND IMAGES WERE CAPTURED FOR EVALUATION. THE PSE REVIEWED THE DATA AND DETERMINED THAT THERE WAS NO DEVICE MALFUNCTION. THERE WAS THE VENT/FIB TACH BEING GENERATED AND RECORDED AT 22:29:12. A RED ALARM PLAYED ON THE FHCMUSURV AND FHMOVR2. AND THEN AT 22:30:33, THE YELLOW ALARM SOUNDED. THEN IT WAS STOPPED A FEW SECONDS LATER. BUT AT 22:35:15, THE VENT FIB/TACH STOPPED AND THE ASYSTOLE WAS GENERATED. THE ASYSTOLE ALARM ENDED THE VENTFIB/TACH ALARM AND THE RED SOUND CONTINUED AT FHCMUSURV AND FHMOVR2. MX40 HAS LATCHED RED ALARMS ONLY, THEY MUST BE SILENCED/ACKNOWLEDGED TO END UNLESS A HIGHER PRIORITY ALARM IS GENERATED. ASYSTOLE DID THAT. YOU CAN SEE THE END AND GENERATE AT THE SAME TIME AT 22:35:15. SEVERAL MINUTES LATER, THE TELE BATTERY WARNING APPEARED AS THEY MENTIONED THAT THEY WERE TESTING OUT THE MX40 AND DID SOME SIMULATION OF THE ALARMS BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. A CLINICAL HARM REVIEW WAS PERFORMED AND DETERMINED THE FOLLOWING: THE REPORTED EVENT OF CARDIAC ARREST AND SUBSEQUENT DEATH WAS REVIEWED BY THE PMS CLINICAL EXPERT. THIS EVENT IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. UPON REVIEW, A CLINICAL AUDIT LOG REVIEW WAS PERFORMED BY A PRODUCT SUPPORT ENGINEER, REVEALING RED ALARMS WERE GENERATED FOR VENT/FIB TACH FOLLOWED BY ASYSTOLE. THE ASYSTOLE ALARM ENDED THE VENT/FIB TACH PER CONFIGURATION. BASED ON THIS INFORMATION, THE DEVICE ALARMED AS CONFIGURED AND LIKELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT; HOWEVER, THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN AT THIS TIME. 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 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 THE ALARM DID NOT SOUND DURING PATIENT CARDIAC ARREST. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929802 INTELLIVUE MX40 WLAN INTELLIVUE MX40 WLAN DSI PHILIPS MEDICAL SYSTEMS 865352 00884838030350

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death