BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21839537 · Received April 15, 2025

    Report

    Report Number
    1218950-2025-000235
    Event Type
    Malfunction
    Date Received
    April 15, 2025
    Date of Event
    April 7, 2025
    Report Date
    April 15, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS TECHNICAL CONSULTANT (TC) ONSITE INVESTIGATED THE REPORTED ISSUE. IT WAS NOTED THAT THE NURSE FOUND THE PATIENT IN DISTRESS, BECAUSE THE PATIENT HAD BLUISH COLOR TO THE SKIN. THE CUSTOMER PULLED UP A STRIP DISPLAY ON THE CENTRAL STATION THAT SHOWED THE INCIDENT IN QUESTION OCCURRED AT 10:29:40AM ON (B)(6) 2025 WITH A RED ASYSTOLE BANNER SHOWING ABOVE THE STRIP DISPLAY. THE TC REQUESTED MX 40 BE RELEASED TO THEM FOR SEQUESTRATION. THE TC WAS INFORMED AT THAT TIME THAT THE PATIENT HAD EXPIRED AND THAT THE MX40 WAS ON ANOTHER PATIENT. THE CUSTOMER SWAPPED OUT THE MX40 AND GAVE TO THE TC. THE TC WENT TO CENTRAL AND VERIFIED WITH STAFF THAT AUDIBLE ASYSTOLE ALARMS WERE AVAILABLE UTILIZING A SEPARATE DEPARTMENT MX40 DEVICE. THE TC CONTACTED ANOTHER TC WHO WAS ONSITE LATER IN THE DAY ON (B)(6) 2025. THIS TC WAS ABLE TO REMOTELY LOG INTO THE CENTRAL STATION AND PULL LOGS FOR THIS INCIDENT. THE LOGS SHOW THAT THE DEVICE HAD ALARMED FOR AN ASYSTOLE AND HAD BEEN ACKNOWLEDGED. (B)(6) 2025 10:30:19 INSPIRA HEALTH VINELAND 2-284 ASYSTOLE ENDED. (B)(6) 2025 10:30:19 INSPIRA HEALTH VINELAND 2-284 ASYSTOLE ENDED. (B)(6) 2025 10:30:19 INSPIRA HEALTH VINELAND 2-284 ASYSTOLE ENDED. (B)(6) 2025 10:30:01 INSPIRA HEALTH VINELAND 2-284 ACKNOWLEDGE (B)(6) 2025 10:30:01 INSPIRA HEALTH VINELAND 2-284 ACKNOWLEDGE (B)(6) 2025 10:29:57 INSPIRA HEALTH VINELAND 2-284 ASYSTOLE GENERATED AT 10:29:46. (B)(6) 2025 10:29:57 INSPIRA HEALTH VINELAND 2-284 ASYSTOLE GENERATED AT 10:29:46. (B)(6) 2025 10:29:57 INSPIRA HEALTH VINELAND 2-284 ASYSTOLE GENERATED AT 10:29:46. THE TC USED A SIMULATOR TO SHOW A HEART RATE OF 70/BPM AND MONITORED THE CENTRAL STATION. THE TC PLACED THE SIMULATOR INTO AN ASYSTOLE; THE HEART RATE TRANSMITTED PROPERLY, AND THE CENTRAL ALARMED FOR ASYSTOLE. THE TC THEN RETURNED THE SIMULATOR TO 70/BPM; THE CENTRAL STATION MONITORED PROPERLY, AND THE ASYSTOLE CLEARED. THIS TEST WAS REPEATED AND ALSO PASSED. THE TC WAS UNABLE TO DUPLICATE THE ORIGINAL COMPLAINT OF THE DEVICE NOT ALARMING. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED WE WERE UNABLE TO REPLICATE THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT CONFIRMED. 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.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX INDICATING THAT AN ASYSTOLE ALARM WAS NOT GENERATED AT THE CENTRAL STATION FOR BED 284 AND THE PATIENT PASSED AWAY. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THE PATIENT DEATH IS BEING ADDRESSED IN A RELATED MX40 COMPLAINT RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106260 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown