BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOLOGS PLATFORM - V2.4.10A

    MDR report key: 22756654 · Received August 8, 2025

    Report

    Report Number
    1000341190-2025-00004
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    June 30, 2025
    Report Date
    August 8, 2025
    Manufacturer
    PHILIPS FRANCE COMMERICAL
    Product Code
    DPS
    PMA / PMN Number
    K212112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE 29-SECOND PAUSE IS NOT FLAGGED BECAUSE IT IS MAINLY CATEGORIZED AS A PURE NOISE. INDEED, DURING INVESTIGATION, I FOUND OUT THE DELINEATION DID NOT DETECT ANY P, QRS, OR T WAVES BETWEEN SECONDS 46 AND 70. THE PROBABILITY SCORES SEEM IN FAVOR OF THE EPISODE BEING BOTH A PURE NOISE AND A VENTRICULAR PAUSE, BUT WE REMOVE THE PAUSE IN CASE OF PURE NOISE. GIVEN THE PRESENT ARTIFACTS AND BASELINE WANDER, THE CONCERNED PART OF THE RECORD IS FLAGGED AS: BAD QUALITY STRIP, MISSING LEAD EPISODE, VENTRICULAR PAUSE AND PURE NOISE. OVERALL, IT IS A DOCUMENTED CASE OF PAUSE DURING NOISE. TO REDUCE FALSE POSITIVES, WE REMOVE PAUSES DETECTED IN A NOISY SIGNAL. THIS SHOULD BE IMPROVED IN OUR NEXT VERSION.

    Description of Event or Problem · 0

    DURING AN INTERNAL REVIEW A PAUSE/ ASYSTOLE EVENT TRANSMITTED ON (B)(6) 2023 WAS REVIEWED BY CLINICAL OPERATIONS AND MEDICAL SAFETY. CARDIOLOGS METRICS SHOWED THAT CARDIOLOGS IDENTIFIED 6 PAUSES (LONGEST DURATION 2.447 SECONDS). IT DID NOT IDENTIFY THE 29 SECOND PAUSE TO MEET CRITERIA FOR A POSITIVE PRIMARY ANALYSIS. CARDIOLOGS IDENTIFIED COMPLETE HEART BLOCK; SECONDARY ANALYSIS BEING DISABLED AT THE TIME OF EVENT PREVENTED THE EVENT FROM BEING GOING TO THE QUEUE FOR MONITORING TECHNICIAN REVIEW. CLINICAL OPERATIONS CONFIRMED THE FINDINGS (2ND DEGREE AVB, TYPE 2 WITH 29.0 SECOND PAUSE AND VENTRICULAR STANDSTILL LASTING 29.0 SECONDS). NO OTHER ARRHYTHMIC EVENTS WERE IDENTIFIED DURING THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250017 CARDIOLOGS PLATFORM - V2.4.10A ELECTROCARDIOGRAM-CARDIOLOGS PLATFORM DPS PHILIPS FRANCE COMMERICAL V2.4.10A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention