BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS PRO, PRINTER, IBP

    MDR report key: 25325302 · Received May 28, 2026

    Report

    Report Number
    3003832357-2026-100322
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    May 28, 2026
    Report Date
    May 28, 2026
    Manufacturer
    REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
    Product Code
    MHX
    UDI-DI
    05060472442932
    PMA / PMN Number
    K201746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE PERSONNEL AND WILL BE INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE TEMPUS PRO INDICATING THAT WHILE INSTALLING A SOFTWARE CONFIGURATION, THE SOFTWARE ENCOUNTERED AN ERROR "ERROR-CRC" WITH ONE OR MORE CONFIGURATION FILES. FOLLOWING THE ERROR, THE USER WAS UNABLE TO ACCESS THE MAIN MENU. AS THE DEVICE WAS REMOVED FROM SERVICE TO PERFORM THE SOFTWARE UPDATE, THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386027 TEMPUS PRO, PRINTER, IBP MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX REMOTE DIAGNOSTIC TECHNOLOGIES LTD. 00-1026-R 05060472442932

    Patients

    Seq Age Sex Outcome Treatment
    1