BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 20148295 · Received September 5, 2024

    Report

    Report Number
    3003832357-2024-00662
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    September 3, 2024
    Report Date
    November 14, 2024
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472440020
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE INDICATES THE ECG CABLE IS NOT CONNECTED. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1888269 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-1004-R 05060472440020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown