BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX MONITOR/DEFIB

    MDR report key: 11768128 · Received May 4, 2021

    Report

    Report Number
    3030677-2021-11295
    Event Type
    Death
    Date Received
    May 4, 2021
    Date of Event
    March 15, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838000018
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT, DURING A CODE BLUE, CPR WAS PERFORMED AND DEFIBRILLATION WAS ATTEMPTED ON A PATIENT USING PADS. THE STAFF WAS UNABLE TO SHOCK THE PATIENT. "NO SHOCK DELIVERED" AND "CANNOT ANALYZE ECG" MESSAGES WERE SEEN AND NOTED ON THE EVENT SUMMARY STRIPS. ADDITIONAL ALARMS WERE SEEN DURING THE EVENT INCLUDING PVC LIMIT 15, VFIB/VTAC, AND LEARNING RHYTHM. THE PATIENT EXPIRED WHILE ATTEMPTING TO PERFORM DEFIBRILLATION. A PHILIPS CLINICIAN REVIEWED THE EVENT FILE. THE DEVICE WAS POWERED ON AND DEFIBRILLATOR PADS WERE PLACED. THE USERS ENTERED THE MANUAL MODE AND ATTEMPTED A TOTAL OF 7 SHOCKS BETWEEN 4:16 ELAPSED TIME (ET) AND 16:11 ET. THE FIRST FOUR SHOCK ATTEMPTS WERE AT 150J AND THE REMAINING THREE SHOCK ATTEMPTS WERE AT 200J. ALL OF THE SHOCKS WERE ABORTED. ¿NO SHOCK DELIVERED¿ MESSAGES WERE DISPLAYED TO THE USERS. THERE WAS A ¿PADS OFF¿ MESSAGE AT 15:03 ET FOLLOWED BY A ¿PADS ON¿ MESSAGE AT 15:58. IT IS NOT KNOWN WHETHER THIS REPRESENTS THE USERS CHANGING THE DEFIBRILLATOR PADS OR WHETHER IT WAS A PADS OFF CONDITION FOR THAT PERIOD OF TIME. THE HOSPITAL BIOMEDICAL ENGINEER REPORTED THAT THE USERS SWITCHED TO A DIFFERENT HEARTSTART MRX DEFIBRILLATOR TO CONTINUE THERAPY. THE BIOMED REPORTED THAT THE HEARTSTART MRX DEVICE PASSED ALL TESTING. THE CUSTOMER REPORTED THAT THE PATIENT WAS OBESE AND HAD ¿VERY OILY SKIN¿. THE HEARTSTART MRX INSTRUCTIONS FOR USE (IFU - PUBLICATION 453564307761) PROVIDES INFORMATION EXPLAINING IMPEDANCE AND THE MESSAGES WHICH WERE SHOWN IN THE EVENT FILE. THE IFU (PAGE 80) PROVIDES THE FOLLOWING INFORMATION TO USERS: ¿IMPEDANCE IS THE RESISTANCE FOUND BETWEEN THE DEFIBRILLATOR¿S PADS WHEN APPLIED TO THE PATIENT¿S BODY THAT THE DEFIBRILLATOR MUST OVERCOME TO DELIVER AN EFFECTIVE DISCHARGE OF ENERGY. THE DEGREE OF IMPEDANCE DIFFERS FROM PATIENT TO PATIENT AND IS AFFECTED BY SEVERAL FACTORS INCLUDING THE PRESENCE OF CHEST HAIR, MOISTURE, AND LOTIONS OR POWDERS ON THE SKIN. THE LOW-ENERGY SMART BIPHASIC WAVEFORM IS AN IMPEDANCE-COMPENSATING WAVEFORM THAT IS DESIGNED TO BE EFFECTIVE ACROSS A WIDE RANGE OF PATIENTS. HOWEVER, IF YOU RECEIVE A "NO SHOCK DELIVERED" MESSAGE, CHECK THAT THE PATIENT¿S SKIN HAS BEEN WASHED AND DRIED AND THAT ANY CHEST HAIR HAS BEEN CLIPPED. IF THE MESSAGE PERSISTS, CHANGE THE PADS AND/OR THE PADS CABLE.¿ THE IFU (PAGE 316) PROVIDES ADDITIONAL INFORMATION IN THE TROUBLESHOOTING CHAPTER. IF USERS RECEIVE THE ¿NO SHOCK DELIVERED, REPLACE PADS NOW¿ MESSAGE, THE IFU DIRECTS THE USER TO ¿MAKE SURE PADS ARE APPLIED PROPERLY. IF THE PROBLEM PERSISTS, REPLACE THE PADS.¿ IF THE USERS RECEIVE THE ¿NO SHOCK DELIVERED, PRESS PADS FIRMLY MESSAGE¿ AND THE IFU ADVISES THE USER OF THE FOLLOWING: ¿POOR PADS CONTACT WITH THE PATIENT. (HIGH IMPEDANCE.) MAKE SURE PADS ARE APPLIED PROPERLY. FIRMLY PRESS PADS ON THE PATIENT¿S CHEST.¿ THIS EVENT IS FULLY CONSISTENT WITH PATIENT IMPEDANCE BEING OUTSIDE THE RANGE FOR THE DELIVERY OF THERAPY. WHEN THE PATIENT IMPEDANCE IS OUTSIDE THE RANGE FOR THE DELIVERY OF THERAPY, USERS ARE ALERTED BY ON-SCREEN MESSAGES. AS THE USERS WERE ALERTED BY ON-SCREEN MESSAGES, AND THE DEVICE PASSED ALL TESTING, THERE IS NO INDICATION THAT THE DEVICE MALFUNCTIONED. THE DEVICE REMAINS WITH THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT, DURING A CODE BLUE, CPR WAS PERFORMED AND DEFIBRILLATION WAS ATTEMPTED ON AN OBESE MALE PATIENT USING DEFIBRILLATION PADS. THE STAFF WAS UNABLE TO SHOCK THE PATIENT. "NO SHOCK DELIVERED" AND "CANNOT ANALYZE ECG" MESSAGES WERE SEEN AND NOTED ON THE EVENT SUMMARY STRIPS. ADDITIONAL ALARMS WERE SEEN DURING THE EVENT INCLUDING PVC LIMIT 15, VFIB/VTAC, AND LEARNING RHYTHM. THE PATIENT EXPIRED WHILE ATTEMPTING TO PERFORM DEFIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664264 HEARTSTART MRX MONITOR/DEFIB DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3535A 00884838000018

    Patients

    Seq Age Sex Outcome Treatment
    1 Death