BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO

    MDR report key: 16930474 · Received May 15, 2023

    Report

    Report Number
    3003832357-2023-00310
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    October 3, 2022
    Report Date
    July 9, 2025
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED TYPE OF REPORTED COMPLAINT FROM PRODUCT PROBLEM TO SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION, DEVICE PROBLEM, PATIENT AND INVESTIGATION CODING UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE TEMPUS PRO DEVICE WAS PREMATURELY SHUT DOWN DURING INTUBATION. NO ALLEGATION OF DEATH OR INJURY. 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 DURING INTUBATION. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION. THE ISSUE WITH VL WAS INITIALLY UNCONFIRMED. THE SERVICE TEAM HAS REVIEWED THE TEMPUS PRO DEVICE IN RELATION TO THE VL ISSUE AND IT HAS BEEN 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 AND CAPA 2968643 IS RAISED. 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

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE VIDEO LARYNGOSCOPE (VL) SHUT DOWN DURING INTUBATION. INFORMATION RECEIVED FROM THE USER STATED THE PATIENT HAD CODED AT THE TOP OF THEIR ATTIC STAIRS. EMERGENCY MEDICAL SERVICES CREW MEMBERS MOVED THE PATIENT TO THE AMBULANCE TO TREAT. THE TEMPUS PRO WAS TURNED ON AND WAS IN USE WITH NO FUNCTIONAL ANOMALIES NOTED. THE VL CABLE WAS PLUGGED IN AND THE VL LIGHT CAME ON, THE CAMERA DISPLAY WAS VISUALIZED AND IMAGE WAS MAXIMIZED. THE USER NOTED A MESSAGE DISPLAYED ON THE TEMPUS PRO INDICATING "RESTART REQUIRED". THE USER THEN POWER CYCLED THE DEVICE BY TURNING THE MONITOR OFF, REMOVING AND REINSERTING THE BATTERY, UNPLUGGING AND PLUGGING AND REMOVING AND REINSERTING THE DEVICE INTO THE SMART MOUNT. THE MONITOR RESTARTED AND ALL FUNCTIONS WORKED AS THEY SHOULD. THE VL WAS UNPLUGGED AND RECONNECTED, AFTER WHICH THE CAMERA FUNCTIONED WITHOUT ISSUE. IT WAS INDICATED THAT THERE WAS NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT. ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIFE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475358 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 NA Unknown Other| L