BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLE ECG (ELECTROCARDIOGRAPH) APP

    MDR report key: 17269487 · Received July 5, 2023

    Report

    Report Number
    MW5119145
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    May 22, 2023
    Report Date
    July 2, 2023
    Manufacturer
    APPLE INC.
    Product Code
    QDA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    FOR FDA APPROVED K201525 THIS PRODUCT OPERATES IN TANDEM WITH APPLE DEVICES USING AN APPLE ID. THE APPLE ID NOT A FULLY SECURED SYSTEM AND THE COMPANY ALLOWS MANIPULATION OF INFORMATION THAT CAN BE USED BY AN MALICIOUS ACTOR REMOTELY; THROUGH HACKING OR OTHER MEANS. TO THE BEST OF MY INVESTIGATION, I FOUND A DEVICE THAT WAS ASSOCIATED WITH THE APPLE ID THAT WAS PREVIOUSLY LINKED TO AN EKG APPLE WATCH (APPROVAL K201525) WAS MANIPULATED USING HARMFUL DATA THAT COULD HAVE RESULTED IN DEATH OR SERIOUS INJURY TO THE OPERATOR THROUGH THE ITUNES FUNCTION. FLAWS IN THE OPERATING SYSTEM OR FLAWS IN APPLE'S POLICIES ALLOW A MALICIOUS ACTOR TO MODIFY INFORMATION THAT MAY EASILY REACH THE END USER AND CAUSE SERIOUS HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015114 APPLE ECG (ELECTROCARDIOGRAPH) APP ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA APPLE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| O