BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLEWATCH 6

    MDR report key: 13514238 · Received February 10, 2022

    Report

    Report Number
    MW5107386
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    October 1, 2021
    Report Date
    February 7, 2022
    Manufacturer
    APPLE, INC.
    Product Code
    QDA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE ECG FUNCTION ON MY APPLEWATCH 6 INITIALLY WORKED AND STOPPED WORKING PROPERLY AFTER ABOUT 4 MONTHS. WHEN I OPENED THE ECG FUNCTION AND PLACED MY FINGER ON THE 'CROWN', BIZARRE ELECTRICAL BLIPS APPEARED, A BEAT OR TWO OF APPARENT HEART ACTIVITY, AND THEN THE COUNTER RESETS TO 30 SEC AND TRIES AGAIN. ONLY ABOUT ONE-TENTH OF THE TIME WILL THE WATCH WORK. I SPENT SEVERAL WEEKS TRYING TO RESOLVE THROUGH APPLE INSTRUCTIONS ONLINE ON RESETTING THE WATCH AND OTHER GENERAL TROUBLESHOOTING, INCLUDING DOWNLOADING SOFTWARE UPDATES WHEN THEY BECAME AVAILABLE. I FIRST CONTACTED APPLE CUSTOMER SERVICE TO REPORT THE PROBLEM AROUND END OF OCTOBER. CUSTOMER SERVICE FINALLY ARRANGED FOR THE WATCH TO BE RETURNED FOR TECHNICAL SERVICE/FIX DURING THIRD WEEK OF NOVEMBER, AND IMMEDIATELY SENT IT BACK TO ME WITH A NOTE SAYING THEY COULD NOT FIND ANYTHING WRONG WITH IT! (IT IS QUITE DISTURBING THAT THEY COULD NOT IDENTIFY THIS ISSUE WITH THE ECG ON THE WATCH!!!) I CONTINUED TO CONTACT APPLE AND EVENTUALLY THE CASE WAS 'ESCALATED'. I PROVIDED VIDEO OF THE MALFUNCTIONING ECG. I ALSO TESTED OTHER PEOPLE'S APPLEWATCH ECG ON MY ARM AND THEY WORKED FINE. I HAVE VIDEO OF MY MALFUNCTIONING WATCH AND ANOTHER PERSON'S FUNCTIONAL WATCH ON MY ARM. (I CAN PROVIDE THIS VIDEO IF NEEDED, BUT IT EXCEEDS THE SIZE ALLOWED WITH THIS FORM SUBMISSION). ON (B)(6) 2022, I RECEIVED A CALL FROM THE REP SAYING THAT PERMISSION HAD BEEN GRANTED FOR THE WATCH TO BE REPLACED, AND THEY SENT ME THE RETURN BOX. I RECEIVED THE REPLACEMENT WATCH IN THE FIRST WEEK OF (B)(6) 2022, AND IT WORKS FINE AT THIS TIME. SADLY, IT TOOK MANY WEEKS AND MANY PERSONAL CONTACTS WITH APPLE TO GET THIS ADDRESSED. THIS SEEMS LIKE A SAFETY ISSUE FOR A DEVICE THAT IS ADVERTISING ABILITY TO DETECT ATRIAL FIBRILLATION. THE MALFUNCTIONING APPLEWATCH 6 WAS (B)(6); MODEL A2291; SERIAL NUMBER (B)(4). ATTACHED IS PHOTO SHOWING THIS INFORMATION. PLEASE ADVISE ANOTHER WAY TO SUBMIT THE VIDEO IF IT IS NEEDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76328 APPLEWATCH 6 ELECTROCARDIOGRAPH SOFTWARE FOR OVER-THE-COUNTER USE QDA APPLE, INC. A2291 VERSION 8.3 (19S55)

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female CITRATE| LEVOTHYROXINE| ONE-A-DAY WOMEN 50+| PREM-PRO | SPIRONOLACTONE| VITAMIN D3