BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPATCH

    MDR report key: 7888816 · Received September 19, 2018

    Report

    Report Number
    7888816
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Report Date
    August 1, 2018
    Manufacturer
    CARDIONET, INC
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED A HOLTER MONITOR. EPATCH WAS REGISTERED TO PATIENT ON CARDIONET. AFTER RECEIVING EPATCH AT END OF MONITORING PERIOD, EKG TECHNICIAN WAS UNABLE TO UPLOAD PATIENT'S DATA TO CARDIONET AS THE WEBSITE STATED PATCH WAS NOT RETRIEVABLE. TECH CALLED CARDIONET AND WAS INFORMED AN I.T REQUEST WAS PUT IN AND THEY WOULD CONTACT BACK WHEN ISSUE WAS RESOLVED. CARDIONET NEVER GOT BACK TO DEPARTMENT ON STATUS OF THE EPATCH. MANUFACTURER RESPONSE FOR E-PATCH, EPATCH (PER SITE REPORTER). TECH CALLED CARDIONET AND WAS INFORMED AN I.T REQUEST WAS PUT IN AND THEY WOULD CONTACT BACK WHEN ISSUE WAS RESOLVED. CARDIONET NEVER GOT BACK TO DEPARTMENT ON STATUS OF THE EPATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731233 EPATCH DETECTOR AND ALARM, ARRHYTHMIA DSI CARDIONET, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 21170 DA