BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 12005459 · Received June 15, 2021

    Report

    Report Number
    3030677-2021-12222
    Event Type
    Death
    Date Received
    June 15, 2021
    Date of Event
    June 9, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THE ALS UNIT WAS UNABLE TO GET A CAPNOGRAPHY READING OR A WAVE FORM ON A CARDIAC ARREST PATIENT. INTUBATION TUBE PLACEMENT WAS CONFIRMED. THE CAPNOGRAPHY RUING WAS REPLACED 3 TIMES WITH NO SUCCESS. THE PATIENT WAS PRONOUNCED DECEASED AT THE SCENE. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE. THE REPORTED ISSUE WAS CONFIRMED AND TRACED TO A FAULTY ETCO2 MODULE. A PHILIPS CLINICIAN REVIEWED THE PATIENT EVENT FILE. IT WAS FOUND THAT THE MRX WAS POWERED ON IN MONITOR MODE WITH PADS ECG AS THE LEAD SOURCE. THE INITIAL ECG RHYTHM WAS ASYSTOLE. THE DEVICE WAS PLACED IN MANUAL THERAPY MODE AT A SELECTED ENERGY OF 200J. CHEST COMPRESSIONS WERE OBSERVED IN THE COMPRESSION WAVE CHANNEL. AT 03:29 ELAPSED TIME, AN ¿ETCO2 ON¿ MESSAGE WAS OBSERVED ALONG WITH A ¿CO2 EQUIPMENT FAILURE ALARM¿ IN THE EVENT SUMMARY. AT 04:32 ELAPSED TIME, A ¿CO2 UNPLUGGED¿ MESSAGE WAS OBSERVED. NO FURTHER MESSAGES OR ALARMS WERE OBSERVED RELATED TO ETCO2 FOR THE REMAINDER OF THE DEVICE USE. THE PATIENT EVENT ENDED AT 32:12 ELAPSED TIME. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER (FSE). THE FSE TRACED THE ISSUE TO A FAULTY ETCO2. ONE ETCO2 MODULE WAS RETURNED FOR FAILURE ANALYSIS. THE REPORTED PROBLEM WAS VERIFIED. ALTHOUGH THE ETCO2 MODULE APPEARED RECOGNIZED BY THE HEARTSTART MRX DEVICE AND PASSED THE CO2 TEST DURING OPERATIONAL CHECK, THE ETCO2 MODULE WAS UNABLE TO READ CO2 VALUE/DATA, THEREFORE IT FAILED TO CALIBRATE (AS CALIBRATION INVOLVES READING OF CO2), AND COULD NOT DISPLAY CO2 WAVEFORM. THE ETCO2 MODULE WAS FOUND TO BE FAULTY AND WAS ARCHIVED. THE FSE REPLACED THE ETCO2 MODULE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS PLACED BACK INTO USE 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 THE ALS UNIT WAS UNABLE TO GET A CAPNOGRAPHY READING OR A WAVE FORM ON A CARDIAC ARREST PATIENT. INTUBATION TUBE PLACEMENT WAS CONFIRMED. THE CAPNOGRAPHY RUING WAS REPLACED 3 TIMES WITH NO SUCCESS. THE PATIENT WAS PRONOUNCED DECEASED AT THE SCENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900288 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC M3536A 00884838006652

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death