BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 18410110 · Received December 28, 2023

    Report

    Report Number
    3003832357-2023-00870
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    November 17, 2023
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC.
    Product Code
    MHX
    UDI-DI
    05060472440013
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A DEFECTIVE DISPLAY. THE DISPLAY ASSEMBLY (RDT DISPLAY ASSEMBLY KIT, PART NUMBER 453564842111) WAS REPLACED RESOLVING THE CUSTOMER¿S COMPLAINT. TESTING AND VERIFICATION WERE COMPLETED SATISFACTORILY (CALIBRATED NBP, CO2, AND TOUCH SCREEN) AND THE DEVICE WAS RETURNED TO SERVICE AT THE CUSTOMER SITE. BASED ON THE INFORMATION AVAILABLE, NO FURTHER ACTION IS NECESSARY AT THIS TIME. 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. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT WHITE SCREEN OCCURRED UPON BOOT UP. NO PATIENT HARM OR INJURY HAS BEEN REPORTED. FURTHER INFORMATION WILL BE SEND UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273109 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) MHX RESPIRATORY TECHNOLOGIES, INC. 00-1007-R 05060472440013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown