BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 20894689 · Received December 10, 2024

    Report

    Report Number
    9610816-2024-000954
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 21, 2024
    Report Date
    January 30, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838121782
    PMA / PMN Number
    K211900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) INTERVIEWED THE CUSTOMER, AND IT WAS DISCOVERED THERE WAS AN ISSUE WITHIN THE BEDSIDE AREA DESPITE A REBOOT OF THE PLANT. THE RSE CONFIRMED THE ISSUE TO BE A BED-TO-BED OVERVIEW FAILURE. AFTER A REBOOT OF THE CENTRAL STATION, THE BED-TO-BED OVERVIEW WAS FUNCTIONAL AGAIN. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME. UPDATED INFORMATION FINDS THIS RECORD TO BE NOT REPORTABLE. ALARMS ARE OCCURRING BOTH ON THE OTHER PATIENTS MONITOR AND ON THE PIC IX. BED TO BED OVERVIEW AT THE INTELLIVUE PATIENT MONITOR IS A SECONDARY ALARM NOTIFICATION SYSTEM AND IS NOT INTENDED FOR PRIMARY NOTIFICATION OF ALARMS, PHYSIOLOGICAL DATA, OR DEMOGRAPHIC DATA. THE INSTRUCTIONS FOR USE (IFU) FOR PIC IX C.03 CONTAINS UPDATED LABELING REGARDING CAREGROUPS AND INTENDED USE.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. E1: REPORTER INSTITUTION PHONE NUMBER: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A PROBLEM WITH INTERMITTENT ALARMS THEY WERE ABSENT AND SOLVED BY A REBOOT, BUT THE PROBLEM RETURNED SHORTLY AFTERWARDS. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2536727 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866389 00884838121782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown