BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO

    MDR report key: 16304869 · Received February 6, 2023

    Report

    Report Number
    3003832357-2023-00027
    Event Type
    Injury
    Date Received
    February 6, 2023
    Date of Event
    January 5, 2023
    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

    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 IT FAILED ECG READING, UNABLE TO OBTAIN 12-LEAD."POST ROSC UNABLE TO OBTAIN 12-LEAD. NO WAVE FORMS PRESENT AND BLANK PRECORDIAL LEAD FIELD." 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. CALIBRATION ONLY IS NEEDED FOR NBP, CO2 AND TOUCH SCREEN. 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

    THE CUSTOMER REPORTED FAILING ECG READING AND BEING UNABLE TO OBTAIN 12-LEAD POST ROSC. NO WAVEFORMS ARE PRESENT AND BLANK PRECORDIAL LEAD FIELD. THE PATIENT WAS WITNESSED WITH CARDIAC ARREST PRESUMING RESPIRATORY ETIOLOGY. 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
    1326235 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 68 YR Male Other