BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 19740425 · Received July 15, 2024

    Report

    Report Number
    3003832357-2024-00537
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    June 19, 2024
    Report Date
    August 5, 2024
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441058
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT DEVICE WON¿T CONNECT TO CORSIUM NETWORK. NO PATIENT HARM OR INJURY HAS BEEN REPORTED. FURTHER INFORMATION WILL BE SEND UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498489 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-1026-R 05060472441058

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown