BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 6132041 · Received November 29, 2016

    Report

    Report Number
    1218950-2016-07493
    Event Type
    Death
    Date Received
    November 29, 2016
    Date of Event
    October 22, 2016
    Report Date
    November 2, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE INVOLVED PATIENT WAS IN CARDIAC ARRESTED AND THE PATIENT DIED. THE USERS OF THE DEVICE FEEL THAT THE DEVICE BEHAVIOR HAD NO IMPACT ON THE PATIENT OUTCOME. THE PATIENT WAS INITIALLY DEFIBRILLATED BY THE FIRST ARRIVING UNIT (A LADDER TRUCK) WITH A PHILIPS HEARTSTART AED. THERE WAS NO CHANGE IN PATIENT CONDITION FOLLOWING THAT EFFORT AND CPR WAS CONTINUED AS THE AMBULANCE CREW ARRIVED WITH THE HEARTSTART MRX. ONCE PADS WERE APPLIED AND THERE WAS NO VIEWABLE RHYTHM WITH THE MRX, THE CREW REVERTED BACK TO THE AED. RESUSCITATION EFFORTS WERE CONTINUED USING ACLS GUIDELINES. THE MRX WAS UTILIZED VIA THE LIMB LEADS TO MONITOR THE PATIENT¿S RHYTHM AND WAVEFORM CAPNOGRAPHY. THE PATIENT WAS REFRACTORY TO ALL EFFORTS IN THE FIELD AND THE EFFORTS UPON DELIVERY TO THE ED. THE DEVICE AND THERAPY CABLES WERE EVALUATED BY A PHILIPS BENCH TECHNICIAN AND THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. THE PADS USED DURING THE EVENT WERE NOT AVAILABLE. THERE WAS NO ELECTRONIC EVENT FILE FOR REVIEW ON THE DEVICE FOR THE DATE/TIME OF THIS INCIDENT. THE DEVICE AND THERAPY CABLES WERE FURTHER EVALUATED BY A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) WITH NO TROUBLE FOUND. ALTHOUGH UNABLE TO REPRODUCE THE ISSUE, BASED ON THE REPORTED SYMPTOM THE PSE ADVISED REPLACEMENT OF THE THERAPY PCA, THERAPY CONNECTOR PORT, AND THE TWO THERAPY CABLES TO ENSURE THE PROPER ACQUISITION OF PADS WAVEFORM AND DELIVERY OF ENERGY. THESE PARTS WERE REPLACED BY THE PHILIPS BENCH. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTING AND WAS RETURNED TO THE CUSTOMER. PHILIPS CANNOT DETERMINE THE CAUSE AS THE REPORTED SYMPTOM COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE WOULD NOT READ ON FOUR SETS OF PADS WITH A PADS CABLE FAILURE ERROR MESSAGE DURING A PATIENT EVENT. THE CUSTOMER RAN OPCHECK AFTER THE INCIDENT, WHICH PASSED. THE CUSTOMER THEN CHANGED OUT THE THERAPY CABLE, RAN OPCHECK AGAIN, AND THE DEVICE FAILED OPCHECK. THE INVOLVED PATIENT WAS IN CARDIAC ARREST AND THE INFORMATION CURRENTLY AVAILABLE INDICATES THAT THE PATIENT DIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE DATE OF DEATH, PATIENT INFORMATION, AND DEVICE IMPACT ON PATIENT OUTCOME ARE NOT CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784054 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death