BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 23000085 · Received September 9, 2025

    Report

    Report Number
    3003832357-2025-000663
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 29, 2025
    Report Date
    December 15, 2025
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472442901
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMDRF CODES / FDA - CODES WITHIN THE USER REPORT AS FOLLOWS: ANNEX A = A2203 / C79146. ANNEX E = E2403 / C106101. ANNEX F = F04 / C171962. THERE WAS NO REPORT OF ACTUAL HARM ASSOCIATED WITHIN THE INCIDENT DESCRIPTION OF THE USER REPORT, HOWEVER, AN ANNEX F CODE OF A DELAY IN DIAGNOSIS WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CONFIRM THE DISCREPANCY AND PROVIDE ADDITIONAL EVENT DETAILS.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REGULATORY AFFAIRS TEAM AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT VIA A USER REPORT ON THE TEMPUS PRO INDICATING THAT USING THE SIDE CHARGING PORT LEADS TO CHARGING SOCKET FAILURE. A REQUEST FOR ADDITIONAL INFORMATION REGARDING THE INCIDENT AND POTENTIAL PATIENT INVOLVEMENT HAS BEEN SENT AND THE RESPONSE IS NOT YET RECEIVED. THERE WAS NO REPORT OF ACTUAL HARM ASSOCIATED WITHIN THE INCIDENT DESCRIPTION OF THE USER REPORT, HOWEVER, AN ANNEX F CODE OF A DELAY IN DIAGNOSIS WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CONFIRM THE DISCREPANCY AND PROVIDE ADDITIONAL EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915851 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-1004-R 05060472442901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown