BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 15885078 · Received November 30, 2022

    Report

    Report Number
    3003832357-2022-00056
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    October 31, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE RIGHT SIDE OF THE SCREEN DOES NOT WORK, AND WOULD NOT ALLOW BLOOD PRESSURE OR 12 LEADS TO OBTAIN. THE FAILED DEVICE HAS BEEN INVESTIGATED AND CONFIRMED THAT THE DEVICE DISPLAY DIDN'T HOLD CALIBRATION MAKING IT VERY DIFFICULT TO HIT ANY FUNCTIONS ON THE RIGHT SIDE OF THE DISPLAY. TO RECTIFY THE REPORTED PROBLEM AND THE FINDINGS ENGINEER REPLACED DISPLAY ASSEMBLY. CALIBRATED THE DEVICE TOUCH SCREEN, NBP AND CO2. THE DEVICE WAS RETURNED TO THE CUSTOMER WITH FULL SPECIFICATIONS. THIS IS THE INITIAL AND FINAL REPORT. THE INVESTIGATION REPORT ATTACHED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440864 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