BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 18606794 · Received January 30, 2024

    Report

    Report Number
    3003832357-2024-00071
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    November 16, 2023
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441058
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION AVAILABLE AND RESULTS OF ADDITIONAL ANALYSIS, THE CAUSE OF THE REPORTED PROBLEM WAS THE DAMAGE TO THE ECG CONNECTORS.. THE DEVICE WAS REPAIRED IN SURESNES/FRANCE, WHERE THE FRONT ENCLOSURE WAS CHANGED. THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED AND WORKING PER SPECIFICATIONS. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE DATA ENTERED IN THIS COMPLAINT RECORD WILL BE UTILIZED FOR PRODUCT QUALITY AND SAFETY IMPROVEMENTS PER THE POST MARKET SURVEILLANCE AND RISK MANAGEMENT PROCESSES. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THERE IS A PROBLEM WITH THE ECG CONNECTOR. 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
    1251077 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 Unknown