BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 21961197 · Received May 5, 2025

    Report

    Report Number
    3003832357-2025-000349
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 10, 2025
    Report Date
    May 5, 2025
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING THE INSPECTION, IT WAS OBSERVED THAT THE DC CONNECTOR WAS NOT FUNCTIONING PROPERLY AND WAS LOOSE. THEREFORE, THE DC CONNECTOR WAS REPLACED ALONG WITH A NEW HEADSET FLEXI ASSEMBLY, FOLLOWING THE AIS 23-2583 TEMPUS PRO OUTER CASE (PRINTER) (ISSUE 6) GUIDELINES. THIS REPLACEMENT ENABLED THE TEMPUS TO RECEIVE DC CHARGE THROUGH THE DC SOCKET. THE DEVICE SUBSEQUENTLY PASSED PERFORMANCE VERIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485749 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