BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO, PRINTER

    MDR report key: 23930941 · Received December 30, 2025

    Report

    Report Number
    3003832357-2025-000943
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    November 29, 2025
    Report Date
    March 31, 2026
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472442925
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING RETRACTED AS INFORMATION RECEIVED INDICATED ONE PATIENT (NOT TWO PATIENTS) WAS BEING MONITORED AT THE TIME OF THE INCIDENT. REFER TO MFR REPORT NUMBER 3003832357-2025-000940 REGARDING PATIENT 1. PLEASE DISREGARD THIS REPORT.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE SHUT DOWN DURING USE WHILST TRANSPORTING PATIENT 2 (TWO PATIENTS WERE BEING TRANSPORTED). THERE WAS PATIENT INVOLVEMENT, HOWEVER NO HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE SHUT DOWN DURING USE WHILST TRANSPORTING PATIENT 2 (TWO PATIENTS WERE BEING TRANSPORTED). THERE WAS PATIENT INVOLVEMENT, HOWEVER NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711622 TEMPUS PRO, PRINTER MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-1024-R 05060472442925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown