BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 17720751 · Received September 11, 2023

    Report

    Report Number
    1218950-2023-00640
    Event Type
    Death
    Date Received
    September 11, 2023
    Date of Event
    August 18, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RECORD REPORTS THE NURSE ENTERED THE PATIENT ROOM AT ON (B)(6) 2023 AT 0420, AND THE RECORD STATES THE PATIENT WAS ¿ACTIVE¿ BUT UNSURE IF THE PATIENT WAS UNDERGOING MONITORING. THE NURSE LEFT AND RE-ENTERED THE ROOM AT 0450 TO REPLACE THE TELEMETRY DEVICE BATTERIES, FOUND THE PATIENT UNRESPONSIVE, AND A CODE WAS CALLED. THE PATIENT WAS RESUSCITATED AND TRANSFERRED TO SCU. THE TECHNICAL INVESTIGATION RESULT INDICATE THAT THE DEVICE WENT OFFLINE DUE TO SOME TYPE OF BATTERY INTERRUPTION. DURING THIS TIME, A ¿NO DATA TELE¿ TECHNICAL INOP WOULD HAVE BEEN DISPLAYED IN THE PATIENT SECTOR AND AN AUDIBLE TONE WOULD HAVE BEEN PROVIDED. PER GFE THE PIC IX WAS CONFIRMED TO BEING USED TO MONITOR OTHER PATIENT BY THE SAME SYSTEM WITH NO REPORTS OF ISSUES. INSPECTION OF THE DEVICE BY THE PHILIPS FIELD SERVICE PERSONNEL AND CLINICAL ENGINEERING REVEALED FLUID INTRUSION IN THE BATTERY TRAY. PRODUCT SUPPORT ENGINEER STATED THE BATTERY ADAPTER TRAY SHOWS WEAR AND SOME SEPARATION OF THE FLEX CIRCUIT FROM THE TRAY & BATTERY COMPARTMENT SHOWS CHEMICAL RESIDUE. REVIEW OF THE LOG INFORMATION PROVIDED INDICATES THAT THE DEVICE WENT OFFLINE DUE TO SOME TYPE OF BATTERY INTERRUPTION. THE CLINICAL AUDIT TRAIL INDICATES THE DEVICE GENERATED ¿NO DATA TELE¿ ALARMS AT 0047, AND THAT ALARM WAS ACKNOWLEDGED AT 0157. THE CLINICAL AUDIT TRAIL INDICATES THE NEXT AUDIT TRAIL ENTRY ¿PAUSE ALL ALARMS¿ AT 0449. BASED ON THE INFORMATION PROVIDED, THE DEVICE GENERATED A ¿NO DATA TELE¿ ALARM WHICH WAS ACKNOWLEDGED. IT WAS ALSO NOTED THAT THE MX40 WAS TESTED BY THE PHILIPS TECHNICAL CONSULTANT WHO WAS ON SITE AND THE DEVICE WAS OPERATION AFTER THE EVENT, NO ISSUES WERE FOUND, BUT THIS WAS AFTER THE DEVICE WAS CLEANED AND BATTERY TRAY REPLACED BY THE BIOMED. 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 MX40 WAS BEING USED AS A TELEMETRY MONITORING DEVICE AT TIME OF EVENT. MX40 ON A PATIENT WENT OFF-LINE FOR 4 HOURS AND PATIENT CODED IN THAT TIME AND LATER DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128715 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death