BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 15750923 · Received November 8, 2022

    Report

    Report Number
    3003832357-2022-00040
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    October 10, 2022
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES (RDT)
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AS DESCRIBED BY THE CUSTOMER, TEMPUS PRO - VL DISPLAYS ¿NO USB CONNECTED¿ WHEN PLUGGED INTO THE PORT. THEY WERE GETTING VL NOT PLUGGED IN ERROR MESSAGE EVEN WHEN THE VL IS PLUGGED IN. IT WAS WORKING INTERMITTENTLY AND CUTS OFF . A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM WHICH IS CURRENTLY BEING INVESTIGATED. AT THE TIME OF REPORTING, THE DEVICE HAS NOT YET BEEN RETURNED FOR INVESTIGATION. FURTHER UPDATES WILL BE PROVIDED WHEN THE DEVICE IS RECEIVED, AND THE INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2227526 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES (RDT) 00-1024-R 05060472441027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other