BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO

    MDR report key: 22868015 · Received August 21, 2025

    Report

    Report Number
    3003832357-2025-000635
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    June 25, 2025
    Report Date
    September 9, 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

    PRODUCT INFORMATION UPDATED DUE TO NEW INFORMATION RECEIVED.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE REPEATEDLY MEASURED DIFFERENT BLOOD PRESSURE MEASUREMENTS WHILE PERFORMING NECESSARY MONITORING OF THE PRESSURE OF A CRITICAL PATIENT FOLLOWING CARDIOPULMONARY RESUSCITATION WHICH INCLUDED MONITORING DURING TRANSPORT. THE USER INDICATED THAT THE MEASURED VALUES WERE NOT DISPLAYED ON THE SCREEN AFTER MONITORING. IT WAS DETERMINED THAT DUE TO THE HEALTH CONDITION OF THE PATIENT AND THE BLOOD PRESSURES MEASURED ON THE SPOT BEFORE TRANSPORT THAT THE PATIENT NEEDED VASOPRESSOR CIRCULATORY SUPPORT. NORADRENALINE WAS INTERMITTENTLY ADMINISTERED AND STOPPED, AND ADJUSTMENTS TO THE RATE OF ADMINISTRATION WITH A LINEAR DISPENSER DURING TRANSPORT WERE ATTEMPTED. THE USER STATED THAT IT WAS NOT POSSIBLE TO HAVE ACCURATE/REAL VALUES OF BLOOD PRESSURE DURING TRANSPORT AND THAT IT WAS NOT POSSIBLE TO STOP IN ORDER TO PERFORM MANUAL (AUSCULTATORY) MEASUREMENT. THE CORRECT SIZE BLOOD PRESSURE CUFF WAS USED ON THE LEFT UPPER LIMB WHILE THE PATIENT WAS RELAXED ON ARTIFICIAL LUNG VENTILATION AND MONITORED. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT AND IT WAS NOTED THE PATIENT WAS HEMODYNAMICALLY UNSTABLE WITH MYOCARDIAL INFARCTION AND WAS QUICKLY TRANSPORTED TO SELECTIVE CORONARY ANGIOGRAPHY.

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE REPEATEDLY MEASURED DIFFERENT BLOOD PRESSURE MEASUREMENTS WHILE PERFORMING NECESSARY MONITORING OF THE PRESSURE OF A CRITICAL PATIENT FOLLOWING CARDIOPULMONARY RESUSCITATION WHICH INCLUDED MONITORING DURING TRANSPORT. THE USER INDICATED THAT THE MEASURED VALUES WERE NOT DISPLAYED ON THE SCREEN AFTER MONITORING. IT WAS DETERMINED THAT DUE TO THE HEALTH CONDITION OF THE PATIENT AND THE BLOOD PRESSURES MEASURED IN THE FIELD BEFORE TRANSPORT THAT THE PATIENT NEEDED VASOPRESSOR CIRCULATORY SUPPORT. NORADRENALINE WAS INTERMITTENTLY ADMINISTERED AND STOPPED, AND ADJUSTMENTS TO THE RATE OF ADMINISTRATION WITH A LINEAR DISPENSER DURING TRANSPORT WERE ATTEMPTED. THE USER STATED THAT IT WAS NOT POSSIBLE TO HAVE ACCURATE/REAL VALUES OF BLOOD PRESSURE DURING TRANSPORT AND THAT IT WAS NOT POSSIBLE TO STOP THE VEHICLE IN ORDER TO PERFORM MANUAL (AUSCULTATORY) MEASUREMENT. IT WAS REPORTED THAT THE CORRECT SIZE BLOOD PRESSURE CUFF WAS USED ON THE LEFT UPPER LIMB WHILE THE PATIENT WAS RELAXED ON ARTIFICIAL LUNG VENTILATION AND MONITORED. OVERALL, THE PATIENT WAS HEMODYNAMICALLY UNSTABLE WITH MYOCARDIAL INFARCTION, WHILE THE DEVICE WAS BEING USED DURING QUICK TRANSPORT TO SELECTIVE CORONARY ANGIOGRAPHY AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370085 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 80 YR Unknown Life Threatening