BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 15759428 · Received November 9, 2022

    Report

    Report Number
    3003832357-2022-00045
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 10, 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
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REPAIR SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE DEVICE SHUTS DOWN WHILE IN THE CRADLE MONITORING THE PATIENT. THE SERVICE ENGINEER INVESTIGATION THE DEVICE AND CONFIRMED REPORTED COMPLAINT UNCONFIRMED, THE UNIT IS WORKING CORRECTLY AT THE BENCH. LOGS ARE BEING PULLED FOR RDT TO EVALUATE. CUSTOMER CONFIRMED THAT THE DOCKING STATION ON SITE WAS THE ISSUE, ONCE THE DOCKING STATION WAS REPLACED ISSUES NO LONGER OCCURRED. CALIBRATED NBP AND CO2. DEVICE FUNCTIONS ARE WORKING CORRECTLY. 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.

    Description of Event or Problem · 0

    AS DESCRIBED BY THE CUSTOMER DEVICE SHUT DOWN WHILE IN THE CRADLE MONITORING THE PATIENT. A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM WHICH IS CURRENTLY BEING INVESTIGATED. AT THE TIME OF REPORTING, THE DEVICE HAS NOT YET BEEN RETURNED FOR INVESTIGATION. FURTHER UPDATES WILL BE PROVIDED WHEN THE DEVICE IS RECEIVED, AND THE INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262619 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