BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOLOGS PLATFORM - V2.4.10A

    MDR report key: 22371545 · Received July 1, 2025

    Report

    Report Number
    1000341190-2025-00003
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 1, 2025
    Manufacturer
    PHILIPS FRANCE
    Product Code
    DPS
    PMA / PMN Number
    K212112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CARDIOLOGS ECG ANALYSIS ALGORITHM HAS DIFFERENT COMPONENTS THAT ARE USED TO ASSEMBLE THE FINAL ALGORITHM DIAGNOSTIC. AMONG THOSE COMPONENTS ARE A PAUSE DETECTOR AND A NOISE DETECTOR DEEP LEARNING MODELS. THOSE 2 COMPONENTS, THE PAUSE AND THE NOISE DETECTOR, ARE RUN INDEPENDENTLY. A POST-PROCESSING STEP IS THEN APPLIED TO COMBINE THEIR OUTPUTS AND CREATE A COHERENT ALGORITHM DIAGNOSTIC. WHEN BOTH A PAUSE AND NOISE ARE DETECTED ON THE SAME ECG SECTION, THE PAUSE DETECTION IS IGNORED BY THE POST-PROCESSING STEP. THIS IS WHAT HAPPENED ON THIS HOLTER. NOISE WAS DETECTED DURING THE 31S PAUSE. THE NOISE DETECTION IS VISIBLE ON THE PLATFORM. THE PAUSE WAS NOT DETECTED DUE TO AN OVER-DETECTION OF NOISE THAT CAUSED PAUSE DETECTION IN THIS SECTION TO BE IGNORED. THE REASON WHY WE DETECT NOISE IN THIS SECTION, DESPITE THE SIGNAL BEING CLEAN, IS THAT PAUSES OF THIS LENGTH ARE VERY UNCOMMON. THE VAST MAJORITY OF THE TIME, AN ABSENCE OF QRS DURING THIS MUCH TIME CAN BE EXPLAINED BY EITHER MISSING SIGNAL, ELECTRODE DISCONNECTION, MICROVOLT SIGNAL OR SIGNAL SATURATION. FOR THIS REASON, THERE ARE VERY FEW EXAMPLES OF TRUE 30S PAUSES IN OUR TRAINING DATABASE AND MOST LOOK-ALIKE EXAMPLES ARE ANNOTATED AS NOISE, BIASING THE NOISE PREDICTION MODEL TOWARDS PREDICTING NOISE FOR ALL SIMILAR ECG SIGNALS.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT FAINTED. BASED ON THE CURRENTLY AVAILABLE INFORMATION, THERE WAS A MISSED NOTIFICATION DUE TO CARDIOLOGS MISINTERPRETATION OF A PAUSE EVENT. THERE IS INDICATION THAT THE MISSED PAUSE EVENT IMPACTED THE PATIENT OUTCOME. THE PROBABILITY OF MEDICALLY REVERSIBLE ADVERSE HEALTH CONSEQUENCES IS REMOTE IN THE OVERALL POPULATION AND IN THE IDENTIFIED AT-RISK POPULATION. SERIOUS ADVERSE HEALTH CONSEQUENCES ARE IMPROBABLE. POTENTIAL IMPACT TO PATIENT IN THE FORM OF DISCOMFORT. BASED ON THE RE-INVESTIGATION OF THIS CASE, THIS COMPLAINT IS NOT REPORTABLE. THE EVENT DID NOT LEAD OR COULD NOT LEAD TO A DEATH OF ANY PERSON. THE EVENT DID NOT LEAD OR COULD NOT LEAD TO A SERIOUS DETERIORATION OF ANY PERSON'S STATE OF HEALTH. THE EVENT DOES NOT PRESENT OR COULD PRESENT A SERIOUS PUBLIC HEALTH THREAT. THIS EVENT IS NOT REPORTABLE, BECAUSE THE PATIENT'S OUTCOME WAS FAINTING BUT DID NOT REQUIRE MEDICAL ATTENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOLOGS PLATFORM MISSED A 30-SECOND PAUSE. THERE WAS NO REPORT THAT THE MISSED PAUSED LED TO A SERIOUS INJURRY DEATH. NO ADDITIONAL INFOMRATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOLOGS PLATFORM MISSED A 30-SECOND PAUSE. THERE WAS NO REPORT THAT THE MISSED PAUSED LED TO A SERIOUS INJURY DEATH. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT FAINTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261822 CARDIOLOGS PLATFORM - V2.4.10A ELECTROCARDIOGRAM-CARDIOLOGS PLATFORM DPS PHILIPS FRANCE 2.4.10A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening