BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 22386659 · Received July 2, 2025

    Report

    Report Number
    1218950-2025-000359
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 8, 2025
    Report Date
    July 2, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE. THE SYSTEM HAD RECOVERED BEFORE THE FSE ARRIVED. THE ISSUE WAS ESCALATED TO PHILIPS TECHNICAL SUPPORT, WHO INDICATED THAT THIS ISSUE WAS RESOLVED IN C.03.10. THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED, AS IT RECOVERED PRIOR TO THE ONSITE VISIT. HOWEVER, BASED ON THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED PROBLEM WAS A SOFTWARE ISSUE. THE FSE FOLLOWED UP WITH THE CUSTOMER BIOMEDICAL ENGINEER AND PROVIDED THE FINDINGS. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. E1: (B)(6).

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON A PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THAT THE WARD 56 CRITICAL CARE UNIT (CCU) ECG SCREEN WAS FREEZING DURING OPERATION. THE SCREEN BECAME UNRESPONSIVE. 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
    220635 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX C.03.04 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown