BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS PRO

    MDR report key: 16571725 · Received March 20, 2023

    Report

    Report Number
    3003832357-2023-00114
    Event Type
    Death
    Date Received
    March 20, 2023
    Date of Event
    January 5, 2023
    Report Date
    September 26, 2024
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PREVIOUSLY REPORTED ON (B)(4) WITH MDR# 3003832357-2023-00034. INVESTIGATION WILL BE HOUSED WITHIN AND REPORTED ON (B)(4) WITH MDR # 3003832357-2023-00034. TYPE OF REPORTED COMPLAINT, PATIENT CODING AND INVESTIGATION CODING UPDATED TO ALIGN WITH (B)(4).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE IS SHOWING DIFFERENT RHYTHMS. THE ISSUE OCCURRED OUTSIDE OF CLINICAL USE. THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REPAIR SERVICE QUEST INTERNATIONAL PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. THE COMPLAINT WAS ESCALATED TO THE TECHNICAL INVESTIGATION AND THE RESULTS INDICATE THAT THE DEVICE IS WORKING AS INTENDED AND COULD NOT CONFIRM COMPLAINT, THE UNIT HAS BEEN TESTED THE LOGS WAS EVALUATED AND ALL FUNCTIONS WITH THE ECG AND OTHERWISE ARE WORKING CORRECTLY. THE DEVICE CALIBRATION ONLY IS NEEDED FOR NBP, CO2, AND TOUCH SCREEN. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT DEVICE IS SHOWING DIFFERENT RHYTHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365875 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 50 YR Female Death| O