BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO

    MDR report key: 22629119 · Received July 28, 2025

    Report

    Report Number
    3003832357-2025-000569
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    July 19, 2025
    Report Date
    September 18, 2025
    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
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED C-CODE TO BETTER ALIGN WITH INVESTIGATION.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING DURING CPR AND PERMANENT CPR ON LUCAS DEVICE CANNOT BE CHECKED WITH CAPNOGRAPHY DURING CPR NOR TRANSPORT. THE CREW RECHECKED SEVERAL TIMES, DISCONNECTED AS WELL AS CHANGED CAPNOMETER POSITION BEFORE AND AFTER REPLACING THE BACTERIAL FILTER, HOWEVER STILL SAYS " CLOGGED CAPNOMETER OUTFLOW" (RECONNECT FILTER LINE). DURING PERMANENT CPR ON LUCAS2 DEVICE, THE PATIENT WAS TRANSPORTED WITHOUT CAPNOGRAPHY. THE CREW AND DOCTOR DO NOT HAVE CO2 (CARBON DIOXIDE) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685056 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 NA Unknown Life Threatening