BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPUS PRO

    MDR report key: 17413323 · Received July 28, 2023

    Report

    Report Number
    3003832357-2023-00496
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    July 11, 2022
    Report Date
    July 28, 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
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED TYPE OF COMPLAINT FROM PRODUCT PROBLEM TO SERIOUS INJURY.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE MONITOR DID NOT START UP WITH A PATIENT WITH CHEST PAIN. THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REPAIR SERVICE PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT THE MONITOR DID NOT START UP WITH A PATIENT WITH CHEST PAIN. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION AND THE RESULTS INDICATE THAT THERE IS A PROBLEM WITH THE SYSTEM BOARD AND SOFTWARE NEEDS AN UPGRADE. UPGRADE 4.30, FUNCTIONAL CHECK AND SAFETY TEST. RDT RAINBOW SYSTEM BOARD ASSEMBLY W/NIBP GOT REPLACED AND THE SOFTWARE WAS UPGRADED TO 4.30. FUNCTIONAL CHECK AND SAFETY TEST PERFORMED SUCCESSFULLY. 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 WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327924 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 Other