BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 12055719 · Received June 24, 2021

    Report

    Report Number
    3030677-2021-12446
    Event Type
    Injury
    Date Received
    June 24, 2021
    Date of Event
    June 18, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838006652
    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 THE DEVICE WAS DID NOT READ RHYTHM PROPERLY DURING ATTEMPT TO SHOCK PATIENT. THE PATIENT WAS FOUND PULSELESS AND APNEIC WITH CPR IN PROGRESS AND PEA ON MONITOR. UPON ARRIVAL AT HOSPITAL, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND RECEIVED SHOCKS, AND WENT INTO SINUS BRADYCARDIA AND ATTEMPTED TO BREATHE ON HIS OWN. THE CUSTOMER IS CONCERNED THE INFORMATION ON THE HEARTSTART MRX WAS NOT CORRECT ESPECIALLY AFTER THE 4TH SHOCK WHEN IT SHOWED AN ASYSTOLE WITH AN ETCO2-34 FOR THE REMAINDER OF THE TRANSPORT AND THEN ON ARRIVAL TO THE HOSPITAL PATIENT CONVERTED INTO A PERFUSING RHYTHM WITHIN THE FIRST 2 MINUTES. AS THERE MAY HAVE BEEN A DELAY IN LIFE SAVING THERAPY, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY. A PHILIPS CLINICIAN REVIEWED THE INFORMATION. A CHANGE IN PATIENT CONDITION DOES NOT NECESSARILY MEAN THE FIRST DEVICE WAS INCORRECT IN WHAT IT REPORTED. NO ECG MONITORING STRIPS OR CASE EVENT FILES WERE PROVIDED TO PHILIPS FOR REVIEW. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE ISSUE. NO PARTS WERE REPLACED. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PLACED BACK INTO USE WITH THE CUSTOMER. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED MALFUNCTION. BECAUSE THE PROBLEM COULD NOT BE RECREATED, THE CAUSE CANNOT BE DETERMINED.

    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 THE DEVICE WAS DID NOT READ RHYTHM PROPERLY DURING ATTEMPT TO SHOCK PATIENT. THE PATIENT WAS FOUND PULSELESS AND APNEIC WITH CPR IN PROGRESS AND PEA ON MONITOR. UPON ARRIVAL AT HOSPITAL, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND RECEIVED SHOCKS, AND WENT INTO SINUS BRADYCARDIA AND ATTEMPTED TO BREATHE ON HIS OWN. THE CUSTOMER IS CONCERNED THE INFORMATION ON THE HEARTSTART MRX WAS NOT CORRECT ESPECIALLY AFTER THE 4TH SHOCK WHEN IT SHOWED AN ASYSTOLE WITH AN ETCO2-34 FOR THE REMAINDER OF THE TRANSPORT AND THEN ON ARRIVAL TO THE HOSPITAL PATIENT CONVERTED INTO A PERFUSING RHYTHM WITHIN THE FIRST 2 MINUTES. AS THERE MAY HAVE BEEN A DELAY IN LIFE SAVING THERAPY, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY. ADDITIONAL DETAILS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955207 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R