BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 16114365 · Received January 6, 2023

    Report

    Report Number
    3003832357-2023-00011
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 12, 2022
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED THE MANUFACTURING SITE AND CONTACT OFFICE ENTITY AS REMOTE DIAGNOSTIC TECHNOLOGIES LTD.

    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 WHEN PLUGGED IN VIDEO LARYNGOSCOPE CAUSES THE MONITOR TO SHUT DOWN. THE SERVICE TEAM HAVE REVIEWED TEMPUS PRO DEVICE IN RELATION TO THE VL ISSUE AND CONFIRMED THAT THE ISSUE IS NOT LIMITED TO THIS DEVICE BUT MAY AFFECT ANY TEMPUS PRO DEVICE USING THE VL. THIS FAILURE MODE WAS ESCALATED TO R&D FOR ADDITIONAL INVESTIGATION. THE PRIMARY ROOT CAUSE WAS IDENTIFIED AS INADEQUATE SOFTWARE VERIFICATION AND VALIDATION. 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 INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT WHEN THE DEVICE IS PLUGGED IN VIDEO LORGI SCOPE CAUSES THE MONITOR TO SHUT DOWN. THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536631 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