BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 19106129 · Received April 15, 2024

    Report

    Report Number
    3003832357-2024-00319
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 18, 2024
    Report Date
    July 2, 2024
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE TEMPUS PRO MEASURED BLOOD PRESSURE 90/50, SECOND MEASUREMENT WITH MINIMUM MEASURED DIFFERENCE, THEN MANUALLY 160/100, THE CUFF WAS ATTACHED CORRECTLY, WITH NO VISIBLE DAMAGE, THE PATIENT WAS CALM, ON THE BED, MANUALLY MEASURING PERFORMED UNDER SAME CONDITIONS WITHIN ABOUT 3 MIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836575 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 Other