BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 5646440 · Received May 11, 2016

    Report

    Report Number
    1218950-2016-02770
    Event Type
    Death
    Date Received
    May 11, 2016
    Date of Event
    April 23, 2016
    Report Date
    April 23, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THE EVENT, THE USERS TESTED THE DEVICE AND WERE ABLE TO SUCCESSFULLY PERFORM A 12 LEAD ECG. THE DEVICE WAS SENT TO THE PHILIPS BENCH FOR EVALUATION. THE DEVICE WAS EVALUATED AND PASSED ALL TESTING. ADDITIONALLY THE DEVICE AND INVOLVED ACCESSORIES WERE TESTED ON A SIMULATOR AND NO PROBLEMS WERE IDENTIFIED. THE ECG CABLES WERE FURTHER EVALUATED BY A QUALITY ENGINEER WITH NO TROUBLE FOUND. THE ELECTRONIC EVENT FILE WAS REVIEWED BY A CLINICAL SPECIALIST. THERE WAS INTERMITTENCY OF THE ECG WAVEFORM THROUGHOUT THE EVENT. TWO TWELVE LEAD ECGS WERE ACQUIRED DURING THE EVENT. FOR BOTH OF THESE 12-LEAD REPORTS, THE ONLY LEAD PRESENT WAS LEAD II. ALL OTHER LEADS WERE MISSING ON THE REPORTS. NOTE THAT IT WAS ALSO REPORTED THE PATIENT WAS SWEATY AND HAD A "GOOD AMOUNT OF HAIR." ALSO NOTE THAT THE CUSTOMER WAS USING NON-PHILIPS ELECTRODES THAT COME IN BAGS OF 25. THIS PREDISPOSES THE ELECTRODES TO BECOMING DRIED OUT WITH RESULTING LEADS ECG ISSUES. A TWO DAY TRAINING IS GOING TO BE HELD WITH THE CUSTOMER BY THE (B)(4) OF ECRA NORTH AMERICA SALES AND SUPPORT TO DISCUSS TROUBLE SHOOTING MEASURES WHEN THERE ARE DIFFICULTIES ACQUIRING ECG MONITORING AND 12 LEAD ECGS. THIS WILL INCLUDE THE IMPORTANCE OF ECG ELECTRODE QUALITY, SKIN PREPARATION, AND LEAD PLACEMENT. THERE IS NO INFORMATION THAT SUPPORTS THAT A MALFUNCTION OF THE DEVICE OCCURRED. THE INABILITY TO ACQUIRE A 12-LEAD ECG IN THIS CASE IS CONSISTENT WITH POOR SKIN CONDITION (SWEATY AND HAIRY) AND USE OF ECG ELECTRODES THAT MAY HAVE BEEN DRIED OUT OR OF POOR QUALITY. THE DEVICE HAS BEEN RETURNED TO THE CUSTOMER SITE FOR USE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WAS UNABLE TO ACQUIRE A 12 LEAD ECG DURING A PATIENT EVENT. THE INVOLVED PATIENT WAS BEING EVALUATED FOR SYMPTOMS OF A STEMI. THE USERS WERE UNABLE TO ACQUIRE A 12 LEAD ECG ON TWO SEPARATE ATTEMPTS DURING TRANSPORT TO THE HOSPITAL. SHORTLY AFTER ARRIVING AT THE HOSPITAL THE PATIENT SUFFERED A CARDIAC ARREST AND DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303862 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death