BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM POCKETECG IV

    MDR report key: 21863062 · Received April 18, 2025

    Report

    Report Number
    3007770164-2025-00001
    Event Type
    Injury
    Date Received
    April 18, 2025
    Date of Event
    December 27, 2024
    Report Date
    April 17, 2025
    Manufacturer
    MEDICALGORITHMICS S.A,
    Product Code
    DSI
    UDI-DI
    05903021560179
    PMA / PMN Number
    K193104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICALALGORITHMICS SENT A REMINDER TO ALL CUSTOMERS ON HOW TO PROPERLY INSPECT THE DEVICE BETWEEN PATIENTS, AND THAT IT IS FORBIDDEN TO UTILIZE MALFUNCTIONING DEVICES FOR PATIENTS' MONITORING. THE COMPANY ALSO IMPROVED INTERNAL PROCESSES BY UPDATING THE JIRA TICKETING SYSTEM BY ADDING A WARNING REMINDING END USERS THAT MANUAL ECG DATA UPLOADS AND OPERATIONS INVOLVING PATIENT INFORMATION REQUIRE VERIFICATION OF THE PATIENT DATA ASSIGNED TO THE UPLOADED ECG.

    Description of Event or Problem · 0

    REPORT RELATES TO SIMILAR PRODUCT, ADVERSE EVENT TOOK PLACE OUTSIDE U.S, WITHIN AUSTRALIA. ON 2025-01-08, MEDICALGORITHMICS S.A. WAS INFORMED OF A SERIOUS INCIDENT IN AUSTRALIA INVOLVING THE POCKETECG IV DEVICE (TYPE P4TR-CA-ADS). THE DEVICE, DESIGNED FOR ONLINE OPERATION, FAILED TO TRANSMIT ECG DATA DURING TWO CONSECUTIVE TESTS. DESPITE THE MALFUNCTION, THE DEVICE SAVED ALL RECORDED ECG DATA LOCALLY ON THE SD CARD, PREVENTING DATA LOSS. INSTEAD OF REPORTING THE ISSUE TO MEDICALGORITHMICS AND UPLOADING ECG DATA FROM THE FIRST SESSION VIA JIRA TICKETING SYSTEM, THE USER INITIATED A NEW TEST WITH ANOTHER PATIENT ON THE SAME DEVICE. DURING THE SECOND TEST THE DEVICE ALSO FAILED TO TRANSMIT DATA. THE DEVICE WAS EVENTUALLY RETURNED TO THE MANUFACTURER FOR ANALYSIS ON MEDICALGORITHMICS' REQUEST. ANALYSIS REVEALED TWO CAUSES FOR THE MALFUNCTION: A DAMAGED SIM CARD SLOT, DISRUPTING MOBILE CONNECTIVITY, AND AN EXPIRED SOFTWARE SECURITY CERTIFICATE. THESE ISSUES PREVENTED DATA TRANSMISSION. DEVICES THAT FAIL TO SEND ECG DATA SHOULD BE REPORTED TO MEDICALGORITHMICS AND RETURNED FOR DIAGNOSTICS AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681661 UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM POCKETECG IV DETECTOR AND ALARM, ARRHYTHMIA DSI MEDICALGORITHMICS S.A, P4TR-CA-ADS 05903021560179

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Life Threatening