BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IWATCH

    MDR report key: 18066997 · Received November 2, 2023

    Report

    Report Number
    MW5147757
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 25, 2023
    Report Date
    October 29, 2023
    Manufacturer
    APPLE, INC.
    Product Code
    QDA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER A SOFTWARE UPDATE (10.1) TO MY APPLE WATCH, THE ECG (ELECTROCARDIOGRAM) ICON DOES NOT APPEAR ON MY WATCH FACE--THERE IS AN EMPTY SPOT WHERE IT WAS. IF I PUSH THE SPOT, THE ECG (ELECTROCARDIOGRAM) FUNCTION ACTIVATES, BUT THE ICON IS NOT THERE. IN THE ATTACHED PHOTO, I HAVE CIRCLED (BOTTOM CENTER) WHERE THE APP IS LOCATED, BUT THE ICON DOES NOT SHOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953158 IWATCH ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA APPLE, INC. 6

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female FEXOFENADINE.| HCTZ (HYDROCHLOROTHIAZIDE).| MAGNESIUM. | METOPROLOL.| SIMVASTATIN.