BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO

    MDR report key: 16868120 · Received May 4, 2023

    Report

    Report Number
    3003832357-2023-00276
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    April 19, 2023
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472441027
    PMA / PMN Number
    K201746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIVE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED. TYPE OF REPORTED COMPLAINT AND DESCRIBE EVENT HAVE BEEN UPDATED TO INDICATE SERIOUS INJURY. DEVICE PROBLEM, HEALTH IMPACT AND PATIENT OUTCOME CODING ALSO UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT TEMPUS PRO WAS UNABLE TO OBTAIN ECG DURING A PATIENT USE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT TEMPUS PRO WAS UNABLE TO OBTAIN ECG DURING A PATIENT USE EVENT. ALTHOUGH NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED, WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO A SERIOUS DETERIORATION IN THE STATE OF HEALTH OF THE PATIENT BECAUSE LIVE-SAVING THERAPY/TREATMENT MAY HAVE BEEN INTERRUPTED/DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487808 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 Unknown Life Threatening