BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 20095201 · Received August 29, 2024

    Report

    Report Number
    3003832357-2024-00647
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 10, 2024
    Report Date
    October 3, 2024
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ETCO2 PORT FELT LOOSE. WHEN SCREWED IN, THE PUMP WILL NOT START TO ACQUIRE READINGS AND SCREEN READS CAPNOMETER FILTER LINE NOT CONNECTED. THE DEVICE WAS REPORTED TO BE IN USE, BUT NO ADVERSE EVENT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096627 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 Other