BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPUS PRO

    MDR report key: 17825872 · Received September 27, 2023

    Report

    Report Number
    3003832357-2023-00670
    Event Type
    Death
    Date Received
    September 27, 2023
    Date of Event
    August 14, 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
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    20SEPT2023 DP: THIS REPORT IS BASED ON INFORMATION PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER, AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO PATIENT MONITOR INDICATING THAT THE DEVICE SCREEN WENT OUT AND RESTART WAS REQUIRED. THIS WAS WHEN THE VIDEO LARYNGOSCOPY WAS IN USE DURING INTERVENTION. IT WAS ALLEGED THAT THE ISSUE MAY HAVE CONTRIBUTED TO PATIENTS DEATH. EVENT DATE: 8/14/2023. REMOTE SERVICE ENGINEER HAS IDENTIFIED THE DEVICE AS WITHIN THE SCOPE OF THE FSN-2023-CC-EC-005. CUSTOMER ADVISED TO COMPLETE FORM AS SW CORRECTION WILL BE SENT TO CUSTOMER WHEN IT IS AVAILABLE. BASED ON THE INFORMATION AVAILABLE THE REPORTED PROBLEM WAS CONFIRMED. A REVIEW OF THE RISK MANAGEMENT FILE WAS PERFORMED, AND THE POTENTIAL SEVERITY IS S1 HAS BEEN IDENTIFIED IN THE RISK DOCUMENT. A CLINICAL HARM REVIEW WAS PERFORMED. THIS EVENT WAS ASSESSED AS  RELATED TO A PRODUCT PROBLEM WITH THE DEVICE. 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 DEVICE IS BACK INTO SERVICE WITH THE LIMITATIONS DESCRIBED IN FSN-2023-CC-EC-005. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    PATIENT OUTCOME AND EVALUATION METHOD CODE WAS UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE VIDEO LARYNGOSCOPE HAD A FAULT WHILE TREATING, THE SCREEN WENT OUT AND RESTART WAS REQUIRED. THIS ISSUE MAY HAS CONTRIBUTED TO PATIENT'S DEATH. FURTHER INFORMATION WILL BE SEND UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984829 TEMPUS PRO MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 05060472441027

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Death