BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO

    MDR report key: 21010253 · Received December 24, 2024

    Report

    Report Number
    3003832357-2024-000881
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 24, 2024
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC.
    Product Code
    MHX
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE CHARGING PORT IS BROKEN. NO PATIENT HARM OR INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2511002 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) MHX RESPIRATORY TECHNOLOGIES, INC. 00-1007-R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown