BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLE WATCH

    MDR report key: 18066989 · Received November 2, 2023

    Report

    Report Number
    MW5147756
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 27, 2023
    Report Date
    October 29, 2023
    Manufacturer
    APPLE, INC.
    Product Code
    QDA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UNABLE TO SEE ECG (ELECTROCARDIOGRAM) ICON AFTER UPDATING (10.1 UPDATE) APPLE WATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953157 APPLE WATCH ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA APPLE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female