BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS PRO

    MDR report key: 16320730 · Received February 8, 2023

    Report

    Report Number
    3003832357-2023-00034
    Event Type
    Death
    Date Received
    February 8, 2023
    Date of Event
    January 5, 2023
    Report Date
    September 26, 2024
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION AND THE RESULTS INDICATE THAT COMPLAINT FOR TEMPUS PRO IS NOT CONFIRMED. THE UNIT HAS BEEN TESTED THE LOGS HAVE BEEN EVALUATED AND ALL FUNCTIONS WITH THE ECG AND OTHERWISE ARE WORKING CORRECTLY. NO PARTS ARE REQUIRED. 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. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION UPDATED. DEVICE PROBLEM CODE UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE DEVICE SHOWED 2 DIFFERENT RHYTHMS BETWEEN PRO AND LS DURING A CARDIAC ARREST WHILE SYNCED. THE PATIENT WAS PRONOUNCED DEAD AT EMERGENCY ROOM. WITNESSED CARDIAC ARREST ON PATIENT ARRIVAL, RHYTHM ASSESSMENT SHOWED V-FIB ON PRO MONITOR AND ASYSTOLE ON THE LS. THE DEFIBRILLATED AND THE MONITOR STILL SHOWED V-FIB WHILE ASYSTOLE ON LS. THE PR (B)(4) WAS SUBMITTED FOR THE COMPLAINT RELATED TO LS . A USER REPORT WAS RECEIVED RELATED TO A REPORTED PRODUCT PROBLEM WHICH IS CURRENTLY BEING INVESTIGATED. FURTHER UPDATES WILL BE PROVIDED WHEN THE INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310212 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 50 YR Female Death