BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFICIA CMS200 CENTRAL MONITORING SYSTEM

    MDR report key: 21663714 · Received March 21, 2025

    Report

    Report Number
    1218950-2025-000158
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    November 28, 2024
    Report Date
    March 21, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838058309
    PMA / PMN Number
    K160951
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS A SUPPLEMENTAL TO 9610816-2024-000938 DUE TO INCORRECT REGISTRATION NUMBER USED. VISUAL AND FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED, AS THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE DETERMINED. THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, OR IF THE DEVICE IS RETURNED, THE COMPLAINT FILE WILL BE REOPENED. BOX E: REPORTING INSTITUTION PHONE #: (B)(6). REPORTER PHONE #:(B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON AN EFFICIA CMS200 CENTRAL MONITORING SYSTEM INDICATING THAT THE EQUIPMENT LOCKED AND STOPPED WORKING; IT STOPPED MONITORING INTENSIVE CARE UNIT (ICU) BEDS. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640860 EFFICIA CMS200 CENTRAL MONITORING SYSTEM EFFICIA CMS200 CENTRAL MONITORING SYSTEM MHX PHILIPS MEDICAL SYSTEMS CMS200 00884838058309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown