BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO

    MDR report key: 16547958 · Received March 15, 2023

    Report

    Report Number
    3003832357-2023-00093
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 13, 2023
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441058
    PMA / PMN Number
    K201746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIVE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE TEMPUS PRO SHOWS AN ECG TRACE ERROR. ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIVE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE TEMPUS PRO SHOWS AN ECG TRACE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711264 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-1026-R 05060472441058

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening