BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX

    MDR report key: 8462172 · Received March 28, 2019

    Report

    Report Number
    1218950-2019-02430
    Event Type
    Death
    Date Received
    March 28, 2019
    Date of Event
    March 11, 2019
    Report Date
    March 14, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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 THE HEARTSTART MRX MONITOR / DEFIBRILLATOR FAILED TO DELIVER A SHOCK WHILE BEING USED TO DEFIBRILLATE A PATIENT. THE PATIENT DIED. THIS PATIENT WITH MULTIPLE COMORBIDITIES, EXPERIENCED A CARDIOPULMONARY ARREST WHILE ADMITTED TO A HOSPITAL. THE PATIENT¿S PRESENTING RHYTHM DURING THE CARDIOPULMONARY ARREST WAS REPORTED TO BE AN ASYSTOLE THEN VENTRICULAR FIBRILLATION. THE HOSPITAL¿S NURSE MANAGER AND RISK MANAGER REPORTED THAT DURING CPR EFFORTS, THE HOSPITAL STAFF ATTEMPTED TO USE THE HEARTSTART MRX MONITOR / DEFIBRILLATOR TO PERFORM CARDIOVERSION IN SYNC MODE WHILE THE PATIENT HAD NO HEART BEAT FOR THE DEVICE TO SYNCHRONIZE ITSELF TO. REVIEW OF THE PROVIDED RHYTHMS STRIPS AND CASE EVENTS SHOWED THE PATIENT HAD A HEART RHYTHM CONSISTENT WITH ASYSTOLE AND VENTRICULAR FIBRILLATION (VFIB) WITH NO DISCERNABLE R-WAVES NOTED THROUGHOUT THE ENTIRE EVENT. ON TWO SEPARATE OCCASIONS DURING THE EVENT, THE DEVICE WAS CHARGED WITH 150 J OF ENERGY AND AUTO DISARMED ITSELF 30 SECONDS LATER DUE TO NO R-WAVES DETECTED. ON ANOTHER OCCASION DURING THE EVENT, THE DEVICE WAS CHARGED WITH 150 J OF ENERGY AND WAS AUTO DISARMED DUE TO A PADS OFF CONDITION. PADS OFF MESSAGES ARE GENERATED WHEN DEFIBRILLATOR PADS ARE NOT CONNECTED TO THE DEVICE OR ARE NOT MAKING PROPER CONTACT WITH THE PATIENT. THE HEARTSTART MRX PROVIDES SYNCHRONIZED CARDIOVERSION THERAPY BY DELIVERING A BRIEF BIPHASIC PULSE OF ELECTRICITY TO THE CARDIAC MUSCLE IMMEDIATELY FOLLOWING AN R-WAVE DETECTED IN THE ECG MEASUREMENT. SYNCHRONIZED CARDIOVERSION ALLOWS SYNCHRONIZED SHOCK DELIVERY WITH THE ECG R-WAVE MONITORED IN WAVE SECTOR 1. IT CAN BE PERFORMED THROUGH EITHER MULTIFUNCTION ELECTRODE PADS OR EXTERNAL PADDLES. ECG SHOULD BE MONITORED THROUGH 3-, 5-, OR 10-LEAD MONITORING ELECTRODES WHEN USING EXTERNAL PADDLES (HEARTSTART MRX M3535A/M3536A INSTRUCTIONS FOR USE (PUBLICATION NUMBER 453564307761, EDITION 2, 2012PAGE 76, 83, AND 85). THE DEVICE WAS WORKING AS INTENDED WHEN THE USERS ATTEMPTED TO PERFORM SYNCHRONIZED CARDIOVERSIONS, A DEFIBRILLATION TECHNIQUE REQUIRING THE PATIENT TO HAVE A QRS COMPLEX TO PERFORM, AND THE DEVICE AUTO DISARMED ITSELF AS PROGRAMMED WITHIN 30 SECONDS EACH TIME, DUE TO NO DISENABLE R-WAVES PRESENT. AS REPORTED BY THE NURSE MANAGER AND RISK MANAGER OF THE HOSPITAL, THIS WAS AN INCIDENT OF USER ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE HEARTSTART MRX MONITOR / DEFIBRILLATOR FAILED TO DELIVER A SHOCK WHILE BEING USED TO DEFIBRILLATE A PATIENT. THE PATIENT DIED. ADDITIONAL DETAILS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255883 HEARTSTART MRX DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death