BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLE WATCH SERRIES 10

    MDR report key: 23166362 · Received September 29, 2025

    Report

    Report Number
    MW5176666
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 23, 2023
    Report Date
    September 23, 2025
    Manufacturer
    APPLE INC.
    Product Code
    QZW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    APPLE WATCH SERIES 10 (MODEL SUFFIX LW/A) WITH IPHONE 15 PRO MAX (LATER IPHONE 17 PRO MAX, SERIAL (B)(6)) IS CONTINUOUSLY COLLECTING BLOOD OXYGEN (SPO2) DATA SINCE APPLE'S (B)(6) 2025 SOFTWARE UPDATE (IOS 18.6.1 / WATCHOS 11.6.1). MEASUREMENTS ARE VISIBLE IN APPLE HEALTH UNDER BROWSE RESPIRATORY BLOOD OXYGEN, CONFIRMING COLLECTION AND IPHONE ANALYSIS. HOWEVER, THE SAME MEASUREMENTS ARE ABSENT FROM HEALTH VITALS, WHICH APPLE PROMOTES AS THE CONSOLIDATED HEALTH DASHBOARD. THIS CREATES A MISLEADING RECORD: USERS REVIEWING VITALS WILL CONCLUDE INCORRECTLY THAT NO SPO2 DATA EXISTS. APPLE SUPPORT CONFIRMED THIS IS "EXPECTED BEHAVIOR" SPECIFICALLY FOR LW/A MODELS. SUPPORT CASES OPENED: CASE ID (B)(4) ((B)(6) 2025) AND (B)(4) THEREAFTER. IN BOTH CASES, ESCALATION TO ENGINEERING WAS DENIED. APPLE HAS NOT DISCLOSED IN PUBLIC ANNOUNCEMENTS, SUPPORT DOCUMENTATION, OR MARKETING THAT LW/A MODELS ARE RESTRICTED FROM SHOWING SPO2 IN VITALS DESPITE ACTIVE DATA COLLECTION. RISK: INCOMPLETE OR MISLEADING HEALTH RECORDS MAY ENDANGER USERS WHO RELY ON VITALS FOR CLINICAL DISCUSSIONS OR SELF-MONITORING. PATIENTS WITH CONDITIONS SUCH AS SLEEP APNEA, COPD, ASTHMA, OR COVID-RELATED HYPOXEMIA COULD BE MISLED INTO BELIEVING OXYGENATION DATA WAS NOT COLLECTED. THIS CREATES A POTENTIAL MEDICAL DEVICE RELIABILITY ISSUE. STEPS TAKEN: VERIFIED SPO2 ENABLED, CONFIRMED DAILY RECORDINGS SINCE (B)(6), RESTARTED DEVICES, RE-PAIRED WATCH DURING MIGRATION FROM IPHONE 15 TO IPHONE 17, CONFIRMED SAME LIMITATION, MULTIPLE SUPPORT CONTACTS. APPLE ACKNOWLEDGES LIMITATION IS TIED TO LW/A MODEL SUFFIX BUT REFUSES TO ADDRESS OR DISCLOSE. REQUEST: FDA EVALUATE WHETHER APPLE'S HANDLING OF SPO2 DATA IN LW/A MODELS CONSTITUTES A DEVICE PERFORMANCE DEFICIENCY OR MISLEADING PRESENTATION OF MEDICAL-ADJACENT HEALTH DATA. CONSIDER REQUIRING APPLE TO (1) CORRECT THE DISPLAY SO ALL COLLECTED SPO2 DATA APPEARS IN VITALS, OR (2) CLEARLY DISCLOSE WHICH MODELS ARE LIMITED SO PATIENTS AND CLINICIANS ARE NOT MISLED. CONSUMERS ARE BEING GIVEN INCOMPLETE VISIBILITY INTO THEIR OWN OXYGENATION DATA DESPITE THE DEVICE COLLECTING AND ANALYZING IT. CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674050 APPLE WATCH SERRIES 10 OVER-THE-COUNTER DEVICE TO ASSESS RISK OF SLEEP APNEA QZW APPLE INC. MWX03LW/A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male