BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 15604230 · Received October 14, 2022

    Report

    Report Number
    3003832357-2022-00032
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Date of Event
    September 16, 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 TEMPUS PRO - MONITOR SHUT DOWN WHEN USING VIDEO LARYNGOSCOPE "IMAGE CAPTURE" WHEN INTUBATING THEIR PATIENT. CUSTOMER CONFIRMED WAS NOT UNPLUGGED FROM THE USB PORT. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION AND THE RESULTS INDICATE THAT AFTER EVENT DEVICE PASSES STARTUP SELF TEST. NO ERROR MESSAGES WERE DISPLAYED AND NO WARNING MESSAGES WAS GIVEN PRIOR TO SHUT DOWN. NO PATIENT HARM NOTED. AT THE BENCH: ENGINEER CONFIRMED COMPLAINT THE UNIT WILL RESTART WHEN THERE ARE A LARGE NUMBER OF PHOTOS ARE TAKEN WITH THE USE OF A VIDEO LARYNGOSCOPE AS FEW AS (B)(6) PHOTOS CAN OVERWHELM THE DEVICE AND REQUIRE A RESTART. 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

    AS DESCRIBED BY THE CUSTOMER 'WHEN THE EMS CREW WERE USING THE VIDEO LARYNGOSCOPE TO INTUBATE THE PATIENT, WHEN THEY USED THE "IMAGE CAPTURE" FEATURE THE TEMPUS PRO DEVICE IMMEDIATELY "SHUT DOWN"'. CREW HAD TO RESTART THE DEVICE TO CONTINUE TO MONITOR PATIENT WITH THE DEVICE UNTIL ARRIVAL AT THE HOSPITAL. THE CUSTOMER REPORTS THE VIDEO LARYNGOSCOPE WAS NOT UNPLUGGED FROM THE USB PORT. A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM WHICH IS CURRENTLY BEING INVESTIGATED. AT THE TIME OF REPORTING, THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. FURTHER UPDATES WILL BE PROVIDED WHEN THE DEVICE INVESTIGATION HAS PROGRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843425 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 Other