BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOLOGS PLATFORM V2.3.13

    MDR report key: 23353745 · Received October 21, 2025

    Report

    Report Number
    1000341190-2025-00007
    Event Type
    Death
    Date Received
    October 21, 2025
    Date of Event
    March 17, 2023
    Report Date
    October 21, 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

    AS AN INTERNAL REVIEW OF THE REPORT OF A THIRD PATIENT DEATH WHILE ON SERVICE, THE EVENTS ON THE COMPLAINT CASE ACTIVITY WERE REVIEWED BY CLINICAL OPERATIONS AND MEDICAL SAFETY. THE ORIGINAL CASE FROM 2023, REFERENCED TWO DIFFERENT STRIPS. IN REVIEWING THIS COMPLAINT, THE MEDICAL SAFETY MANAGER IDENTIFIED THAT THE FIRST MDR LISTED (1000341190-2023-00001) REFERENCES TWO STRIP IDS IN THE COMPLAINT. DURING THE INVESTIGATION & RE- ANALYSIS INTO THE CASE, THOSE TWO STRIP IDS ARE ASSOCIATED WITH 2 DIFFERENT PATIENTS, SO IT WAS CONCLUDED THAT A SECOND SEPARATE MDR SHOULD HAVE BEEN SUBMITTED AT THE TIME.

    Description of Event or Problem · 0

    THE CUSTOMER MENTIONED TWO RECORDINGS WHERE CARDIOLOGS MISSES VF AND ASYSTOLE IDENTIFICATION IN THE ECG ANALYSIS REPORT. CUSTOMER LATER FOUND OUT THAT PATIENT PASSED AWAY. ESCALATION REQUIRED FOR MISSED PAUSE FOR VF AND ASYSTOLE IDENTIFICATION EVENTS REPORTED BY THE CLIENT PREVENTICE SOLUTIONS (FORMER CARDIOLOGS TECHNOLOGIES CLIENT) ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254319 CARDIOLOGS PLATFORM V2.3.13 ELECTROCARDIOGRAM-CARDIOLOGS PLATFORM, DPS PHILIPS FRANCE COMMERICAL V2.3.13

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death