BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO

    MDR report key: 19006456 · Received March 29, 2024

    Report

    Report Number
    3003832357-2024-00283
    Event Type
    Injury
    Date Received
    March 29, 2024
    Report Date
    July 23, 2024
    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
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED EVALUATION METHOD, EVALUATION RESULTS, AND CONCLUSION CODE GRIDS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE DEVICE GAVE INACCURATE BP READINGS. PER PROVIDER, "I HAD A MINIMALLY RESPONSIVE CODE STROKE PATIENT AND WITH 80¿S MONITOR I GOT BP READINGS OF 180/130 BACK-TO-BACK WITH NUMBERS LIKE 40/20."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2254034 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