BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEPIMAGE RING/SOFTWARE

    MDR report key: 21515626 · Received March 4, 2025

    Report

    Report Number
    MW5167204
    Event Type
    Malfunction
    Date Received
    March 4, 2025
    Date of Event
    February 27, 2025
    Report Date
    February 28, 2025
    Manufacturer
    MYCARDIO
    Product Code
    MNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ISSUE WITH SLEEPIMAGE APP/RING USED FOR AT HOME SLEEP STUDY. SOFTWARE APP WOULD NOT SYNC DATA DESPITE MANUFACTURER'S INSTRUCTIONS, ONLY 1 HOUR OF DATA RECORDED. THIS RESULTED IN LOST DATA. CANNOT DIAGNOSE PATIENT BECAUSE NO DATA AVAILABLE. SOFTWARE APP PAGE HAS MULTIPLE REPORTS OF THIS SAME ISSUE. PLEASE INVESTIGATE. PLEASE INVESTIGATE THE SOFTWARE COMPONENT OF THIS DEVICE. MULTIPLE USERS REPORT THE SAME ISSUE ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827582 SLEEPIMAGE RING/SOFTWARE VENTILATORY EFFORT RECORDER MNR MYCARDIO

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male