BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 15322920 · Received August 30, 2022

    Report

    Report Number
    3003832357-2022-00023
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    August 3, 2022
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES (RDT)
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AS DESCRIBED BY THE CUSTOMER 'MONITOR TENDS TO GIVE INACCURATE 02 SAT READINGS. THE TEMPUS WILL GIVE A READING OF SAY 70% WHEN THE PATIENT'S PRESENTATIONS SIMPLY DOESN'T REFLECT. THE CREWS ADVISE ME THAT THEY WILL CHANGE OVER TO ONE OF OUR PORTABLE O2 SAT MONITORS AND GET A READING IN THE 90'S. I HAVE ALSO RECEIVED REPORTS OF FLUCTUATING HEART RATES. THE MONITOR WILL DISPLAY A HEART RATE OF SAY 20 TO 30, WHEN THE PATIENT'S PALPABLE PULSE IS 60-70. WE HAVE CHECKED TO ENSURE THAT THE HEART RATE IS READING OFF OF THE ECG AND NOT THE O2 SAT PLETH THINKING THIS COULD HAVE BEEN THE REASON FOR THE INACCURATE RATES. SCREEN HAS ALSO FROZEN AT TIMES. DEVICE RETURN IS PLANNED TO DO AN INVESTIGATION AND ROOT CAUSE ANALYSIS.

    Description of Event or Problem · 0

    AS DESCRIBED BY THE CUSTOMER 'MONITOR TENDS TO GIVE INACCURATE 02 SAT READINGS. THE TEMPUS WILL GIVE A READING OF SAY 70% WHEN THE PATIENT'S PRESENTATIONS SIMPLY DOESN'T REFLECT. THE CREWS ADVISE ME THAT THEY WILL CHANGE OVER TO ONE OF OUR PORTABLE O2 SAT MONITORS AND GET A READING IN THE 90'S. I HAVE ALSO RECEIVED REPORTS OF FLUCTUATING HEART RATES. THE MONITOR WILL DISPLAY A HEART RATE OF SAY 20 TO 30, WHEN THE PATIENT'S PALPABLE PULSE IS 60-70. WE HAVE CHECKED TO ENSURE THAT THE HEART RATE IS READING OFF OF THE ECG AND NOT THE O2 SAT PLETH THINKING THIS COULD HAVE BEEN THE REASON FOR THE INACCURATE RATES. SCREEN HAS ALSO FROZEN AT TIMES. THE DEVICE LOG FILES WAS INVESTIGATED BY RDT AND NO PROBLEM WAS FOUND. THE DEVICE HOWEVER REPORTED SEVERAL ' ECG LEAD OFF' ERRORS THROUGH OUT THE LOGS. THIS COULD BE AN INDICATION THAT THIS CABLE WAS BEING USED INCORRECTLY OR THERE IS A FAULT WITH THE CABLE. IT IS RECOMMENDED THAT CUSTOMER BE SUPPLIED WITH A NEW ECG AND SPO2 CABLE. THE CUSTOMER SHOULD NOTIFY RDT IF THE PROBLEM PERSISTS WITH THE NEW CABLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243543 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES (RDT) 00-1024-R 05060472441027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other