BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 19726435 · Received July 11, 2024

    Report

    Report Number
    3003832357-2024-00534
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Date of Event
    July 3, 2024
    Report Date
    September 20, 2024
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE SCREEN IS NOT CALIBRATING AND STILL MESSING UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236297 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-1024-R 05060472441027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown