BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO

    MDR report key: 20316641 · Received September 26, 2024

    Report

    Report Number
    3003832357-2024-00707
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    January 18, 2024
    Report Date
    September 26, 2024
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472440020
    PMA / PMN Number
    K201746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE DEVICE RECEIVED AN ERROR MESSAGE AND THEN LOCKED UP, RENDERING IT UNABLE TO OBTAIN PATIENT VITALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708790 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 Life Threatening