BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21316301 · Received February 5, 2025

    Report

    Report Number
    1218950-2025-000040
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    November 25, 2024
    Report Date
    February 5, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS A SUPPLEMENTAL TO 9610816-2024-000996 DUE TO INCORRECT REGISTRATION NUMBER USED. A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND CONFIRMED THE ISSUE WAS TO THE BED LABEL WAS UNASSIGNED FROM THE WRONG CENTRAL MONITOR. THE FSE RESOLVED THE CONFIGURATION ISSUE. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE DISPLAY MONITORS ARE CONFIGURED IMPROPERLY AND ALARMING FOR THE WRONG PATIENTS, SOUTH MONITOR IS NORTH, NORTH MONITOR IS SOUTH. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043859 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown