BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOLOGS PLATFORM, VERISON 2.4.3

    MDR report key: 21964051 · Received May 5, 2025

    Report

    Report Number
    1000341190-2025-00002
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    April 7, 2025
    Report Date
    May 5, 2025
    Manufacturer
    PHILIPS FRANCE COMMERICAL
    Product Code
    DPS
    PMA / PMN Number
    K212112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A MISSED PAUSE WAS REPORTED. IN THE CURRENT VERSION OF THE SOFTWARE (2.4.X) : PAUSES OVERLAPPING WITH PURENOISE ARE REMOVED. AS A RESULT, ALL PAUSES ARE FILTERED IN THIS SPECIFIC STRIP. : EXTREME BRADICARDIAS OR VERY LONG PAUSES ARE REALLY RARE. 99% OF THE TIME, WHEN THE QRS DETECTION IS SO "SLOW" IT MEANS THAT THE SIGNAL IS NOT INTERPRETABLE: EITHER THERE ARE MISSING DATA, OR THERE ARE NO CARDIAC BEATS BUT JUST SOME ARTIFACTS WRONLY DETECTED AS QRS. BECAUSE OF THIS, THE NOISE DETECTION SIGNAL IS BIASED TOWARDS PREDICTING NOISE WHEN THERE IS EXTREMELY SLOW RHYTHM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT PRESENTED TO THE DOCTOR'S FEELING FAINT AND DIZZINESS. THE MCOT TRIGGERED A PAUSE EVENT AT (B)(6) 2025 AT 0834AM EST AND WAS RECIEVED AS AN AUTO-PROCESSED EVENT. THE EVENT WAS DETERMINED TO BE INTERMITTENT COMPLETE HEART BLOCK WITH PREMATURE VENTRICULAR CONTRACTIONS (PVC(S)) AND MULTIPLE PAUSED WERE NOTED, WITH THE LONGEST PAUSE AT 4.7 SECONDS. A REVIEW OF CARDIOLOG METRICS DETERMINED CARDIOLOG DID NOT IDENTIFY HEART BLOCK OR PAUSE. AS A RESULT, THE EVENT WAS NOT PRESENTED TO A MONITORING TECHNICIAN FOR REVIEW. BASED ON THE AVAILABLE INFORMATION, THERE WAS A MISSED 4.7 SECOND PAUSE AND MISSED INTERMITTENT COMPLETE HEART BLOCK DUE TO CARDIOLOGS MISINTERPRETATION OF THE ARRHYTHMIC EVENT. THERE IS INSUFFICIENT EVIDENCE TO DETERMINE IF THE MISSED EVENT DELAYED PACEMAKER PLACEMENT OR IMPACTED PATIENT OUTCOME. THE PATIENT SOUGHT MEDICAL ATTENTION WHEN SYMPTOMATIC, AND PACEMAKER PLACEMENT WAS ORDERED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819399 CARDIOLOGS PLATFORM, VERISON 2.4.3 ELECTROCARDIOGRAM-CARDIOLOGS PLATFORM DPS PHILIPS FRANCE COMMERICAL 2.4.3

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention