BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 20003768 · Received August 20, 2024

    Report

    Report Number
    1218950-2024-00590
    Event Type
    Death
    Date Received
    August 20, 2024
    Date of Event
    July 24, 2024
    Report Date
    October 22, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    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

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER INDICATING THAT ON (B)(6) 2024 AT 22:05, THE MONITOR TECHNICIAN OBSERVED THAT THE PATIENT IN ROOM (B)(6) HAD A WIDENING QRS COMPLEX. DESPITE THE SEVERITY OF THE ARRHYTHMIA, THE TELEMETRY MONITOR DID NOT ALARM. HOWEVER, THE MONITOR TECHNICIAN PROMPTLY ALERTED THE NURSE, WHO FOUND THE PATIENT UNRESPONSIVE AND PULSELESS. A CODE BLUE WAS INITIATED AND THE PATIENT WAS IMMEDIATELY CONNECTED TO THE PHILIPS DEFIBRILLATOR; THE PATIENT EXPIRED. THE CODE BLUE LOG STARTS WITH ASYSTOLE DOCUMENTED AT 22:10, AS CONFIRMED BY THE PHILIPS DEFIBRILLATOR MONITOR. THE CENTRAL MONITORING SYSTEM DID NOT DETECT THE LETHAL ARRHYTHMIA AND DID NOT ALARM UNTIL 22:13. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE VALIDATED THAT THE DEVICE WAS WORKING AS DESIGNED AND ABLE TO TRIGGER ASYSTOLE ALARMS CORRECTLY. THE FAILURE TO TRIGGER AN ALARM WAS NOT REPLICATED. AUDIT LOG DATA WAS RETRIEVED. A REVIEW OF THE LOG DATA BY A PRODUCT SUPPORT ENGINEER (PSE) FOR THE INDICATED TIME PERIOD FOUND NO ARRHYTHMIA ALARMING PRIOR TO 22:10. THE CENTRAL MONITORING SYSTEM DID NOT ALARM UNTIL 22:13. THE DEVICE DOES NOT ALARM FOR A WIDENING QRS CONDITION. THE DEVICE WILL PRODUCE PREMATURE VENTRICULAR CONTRACTION (PVC) ALARMS ONCE A BEAT HAS BEEN LABELED V [VENTRICULAR ECTOPIC]. IF THE BEAT IS RECOGNIZED AS A V AND THE YELLOW PVC ALARMS ARE OFF THEN THERE WOULD BE NO ALARM. A GOOD FAITH EFFORT WAS MADE TO OBTAIN THE STRIPS FROM THE EVENT. HOWEVER, NO PATIENT STRIPS WERE SAVED FROM THE EVENT AND THERE WERE NO PRINTOUTS. THEREFORE, NO ADDITIONAL INVESTIGATION COULD BE PERFORMED. THE ST/AR (ST AND ARRHYTHMIA) ALGORITHM IS A MULTI-LEAD ECG ALGORITHM DESIGNED FOR ARRHYTHMIA, ST SEGMENT AND QT MONITORING. THE ARRHYTHMIA ALGORITHM CAN RUN AS SINGLE-LEAD ANALYSIS OR MULTI-LEAD ANALYSIS. INFORMATION WILL BE PROVIDED TO THE CUSTOMER FROM THE ARRHYTHMIA MONITORING ST/AR ALGORITHM APPLICATION NOTE TO RESOLVE THE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO (B)(6) 2016 SO NO UDI REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE STAFF DID NOT HEAR THE ALARM FOR ASYSTOLE AT THE TIME OF DEATH ON A PACED DO NOT RESUSCITATE (DNR) PATIENT. THE FACILITY BIOMEDICAL ENGINEER INDICATED PACER DETECTION WAS TURNED ON AT THE TIME OF THE EVENT. AN INITIAL REVIEW OF THE CLINICAL AUDIT LOG BY REMOTE SERVICE REVEALED THE PATIENT HAD A PROGRESSION OF ARRHYTHMIA ALARMS WHICH ULTIMATELY DETERIORATED TO ASYSTOLE. THE HOSPITAL CSU CLINICAL SUPERVISOR FURTHER CLARIFIED THE ALLEGATION TO POINT TO A DISCREPANCY BETWEEN THE PHILIPS DEFIBRILLATOR MONITOR AND THE CENTRAL MONITORING SYSTEM. THE CODE BLUE LOG STARTS WITH ASYSTOLE DOCUMENTED AT 22:10, AS CONFIRMED BY THE PHILIPS DEFIBRILLATOR MONITOR. THE CENTRAL MONITORING SYSTEM DID NOT DETECT THE LETHAL ARRHYTHMIA AND DID NOT ALARM UNTIL 22:13. THE PHILPS FIELD SERVICE ENGINEER AND THE HOSPITAL BIOMEDICAL ENGINEER ARE CURRENTLY INVESTIGATING WHETHER THE DEFIBRILLATOR'S TIME IS SYNCED WITH THE PHILIPS CENTRAL MONITORING SYSTEM. THE INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066109 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death