BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIO AT

    MDR report key: 16092146 · Received January 3, 2023

    Report

    Report Number
    3007208829-2023-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    August 30, 2021
    Report Date
    December 8, 2022
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC
    Product Code
    DSI
    PMA / PMN Number
    K163512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS HOSPITALIZED FOR FAINTING. THE DEVICE WAS PLACED ON THE PATIENT ON (B)(6) 2021 IN THEIR PHYSICIAN¿S OFFICE. THERE WERE NO TRANSMISSIONS RECEIVED FOR 5 DAYS AT WHICH POINT IRHYTHM CONTACTED THE ACCOUNT TO NOTIFY THEM. THE PRELIMINARY INVESTIGATION REVEALED GATEWAY A128120837 WAS NOT SUCCESSFULLY ACTIVATED, AND NO TRANSMISSIONS WERE RECEIVED DURING THE WEAR PERIOD. THE GATEWAY FAILED TO ACTIVATE BECAUSE IT ENCOUNTERED A LOW BATTERY FATAL ERROR. THERE WERE CLINICALLY ACTIONABLE ARRHYTHMIAS WHICH DID NOT GET TRANSMITTED TO IRHYTHM¿S IDTF (42 CFR 410) AND THEREFORE NEITHER WAS THE PHYSICIAN NOTIFIED.

    Description of Event or Problem · 0

    PER AN UPDATE TO THE CRITERIA FOR REPORTABLE EVENTS, THIS MDR IS BEING SUBMITTED. ON 08DEC2022 A PATIENT WAS HOSPITALIZED WHILE WEARING THE ZIO AT ECG MONITOR. THE ORIGINAL EVENT OCCURRED ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO FAINTING WHILE WEARING THE ZIO AT ECG MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418295 ZIO AT DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Female Hospitalization