BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO, PRINTER

    MDR report key: 22512635 · Received July 15, 2025

    Report

    Report Number
    3003832357-2025-000549
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    July 10, 2025
    Report Date
    September 24, 2025
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    PMA / PMN Number
    K201746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY REMOTE SERVICE ENGINEER RSE AND IS CURRENTLY UNDER INVESTIGATION BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING ON TWO OCCASIONS THE SCREEN LOCKED UP AND RENDERED THE MONITOR INOPERABLE. ON (B)(6) THE SECOND OCCURRENCE WAS DOCUMENTED. THE CUSTOMER REPORTED THE DEVICE HAS NOT BEEN DROPPED OR DAMAGED. THE CREW ATTEMPTED RE-STARTING MONITOR IN START-UP MODE AND RE-CALIBRATING THE TOUCHSCREEN, HOWEVER, THIS DID NOT RESOLVE THE ISSUE, AND A SECOND AMBULANCE WAS DISPATCHED TO REPLACE THE MONITOR. THERE WAS A DELAY IN CARE NOTED, HOWEVER, THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED ONCE THE KNOWN WORKING DEVICE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138199 TEMPUS PRO, PRINTER MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-1024-R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening