BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 15409550 · Received September 13, 2022

    Report

    Report Number
    3003832357-2022-00028
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 18, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AS DESCRIBED BY THE CUSTOMER 'WILL NOT BOOT UP AND POWERED DOWN WHILE ON A PATIENT'. DEVICE RETURNED TO THE SERVICE BENCH FOR THE INITIAL EVALUATION AND UPON INTERNAL INSPECTION, THE TRIZEPS BOARD IS NOT SEATED CORRECTLY CAUSING THE DEVICE TO NOT BOOT. ONCE THE TRIZEPS WAS SEATED CORRECTLY THE DEVICE FUNCTIONS ALL WORKED CORRECTLY. CALIBRATED NBP AND CO2. THIS FAILURE IS UNDER MONITORING FOR FURTHER TRENDING AND ROOT CAUSE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534690 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