BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO

    MDR report key: 20314989 · Received September 26, 2024

    Report

    Report Number
    3003832357-2024-00709
    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 INACCURATELY IDENTIFIED V-FIB MULTIPLE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829973 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