BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 17315681 · Received July 13, 2023

    Report

    Report Number
    3003832357-2023-00472
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Date of Event
    June 23, 2023
    Report Date
    July 13, 2023
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING A BATTERY METER FAILURE. A DIAGNOSTIC WAS PERFORMED, REQUIRING A PART TO BE REPLACED (SBC BOARD). THE CUSTOMER WAS PROVIDED WITH THE PART TO RESOLVE THE ISSUE. FOR THIS CUSTOMER, (B)(4) HEALTHCARE REPAIRS ARE COMPLETED OUTSIDE OF PHILIPS CONTROL. BASED ON THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED PROBLEM WAS A SBC BOARD. THE REPORTED PROBLEM WAS CONFIRMED. HOWEVER, THE ROOT CAUSE OF THE FAILURE CANNOT BE DETERMINED WITHOUT THE RETURN OF THE DEVICE FOR FAILURE ANALYSIS WHICH IS NOT REQUIRED BY THE CUSTOMER. 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. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER EVALUATION IS WARRANTED AT THIS TIME. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209505 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 Unknown Other