BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODY GUARDIAN MINI REMOTE CARDIAC MONITOR

    MDR report key: 19449819 · Received May 31, 2024

    Report

    Report Number
    MW5155698
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    January 22, 2024
    Report Date
    May 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6) HEALTH SYSTEM HAS BEEN NOTIFIED BY PREVENTICE/BOSTON SCIENTIFIC OF AN ISSUE WITH THEIR ALGORITHM THAT IDENTIFIES VENTRICULAR TACHYCARDIA (VT) FOR MCT/CEM STUDIES (BODY GUARDIAN MINI). THE SOFTWARE ISSUE MAY CAUSE VT TO NOT BE IDENTIFIED RESULTING IN THE HEALTH CARE FACILITY NOT RECEIVING A CRITICAL ALERT NOTIFICATION OR REPORT, AND THE VT STRIP/EVENT NOT BEING INCLUDED IN THE END OF SERVICE REPORT SENT TO THE HEALTHCARE FACILITY. SOME VT IS BEING CAUGHT AND SOME IS MISSED; THE AMOUNT OF EACH IS UNKNOWN. THIS IS NOT AN EQUIPMENT ISSUE BUT SOFTWARE ISSUE. BOSTON SCIENTIFIC IDENTIFIED THE PROBLEM 04/04/2024 AND NOTIFIED (B)(6) 04/16/2024. AT THE PRESENT TIME WE ARE UNAWARE OF PATIENT HARM BUT ARE INVESTIGATING. BODYGUARDIAN MINI IS THE DEVICE, BUT THE ISSUE IS WITH THE SOFTWARE. BOSTON SCIENTIFIC THIS IS A SOFTWARE ISSUE. NOT A MONITOR PROBLEM BUT A SOFTWARE PROBLEM. MANUFACTURER REPORTED TO US. BOSTON SCIENTIFIC CARDIAC DIAGNOSTICS 1717 N. SAM HOUSTON PKWY W, HOUSTON, TX 77038.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173435 BODY GUARDIAN MINI REMOTE CARDIAC MONITOR DETECTOR AND ALARM, ARRHYTHMIA DSI BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown