BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC IX HARDWARE

    MDR report key: 16601233 · Received March 23, 2023

    Report

    Report Number
    1218950-2023-00148
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    February 26, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) CONNECTED TO THE SITE AFTER RECEIVING PERMISSION FROM THE CUSTOMER. AS THE NETWORK IS CUSTOMER SUPPLIED, THE RSE WAS UNABLE TO ASSIST FURTHER. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE WHILE LOOKING AT THE DEVICE STATUS IDENTIFIED IT APPEARS THAT SOME OF THE BEDSIDE MONITORS WERE IN A DIFFERENT SUBNET THAN THE OTHERS. THE FSE IDENTIFIED IDF CLOSET G-14 AS HAVING THE SWITCH TO HOST THE BEDSIDE MONITORS. THE FSE WORKED WITH THE BIOMED, THE TRACED OUT CABLES FOR THE ROOMS THAT WERE QUESTION AND THEY HAD BEEN MOVED TO ANOTHER SWITCH FOR UNKNOWN REASONS. THE FSE RECOMMENDED THAT THEY BE RETURNED TO ORIGINAL SWITCH SO THEY CAN BE ON THE SAME SUBNET. THE FACILITY HAS TOO MANY BEDSIDE MONITORS FOR THE ORIGINAL SWITCH NOW, THE FSE AND BIOMED PUT AS MANY OF THEM AS THEY COULD ON THE ONE SWITCH AND IT WILL WORK ON GETTING ANOTHER SWITCH IN THAT CLOSET SO THEY CAN HAVE EVERYTHING ON SAME SUBNET. THE FSE WORKED WITH BIOMED TO FORCE SOME RED ALARMS TO TEST IF BEDSIDE DISPLAY WAS WORKING PER THEIR EXPECTATIONS, ALL TESTING WAS SUCCESSFUL. THIS RECORD IS NO LONGER CONSIDERED TO BE A REPORTABLE PRODUCT PROBLEM. NO DEATH, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED TO HAVE OCCURRED OR WAS ALLEGED AS A RESULT OF THIS ISSUE, NOR IS THIS ISSUE LIKELY TO CAUSE OR CONTRIBUTE TO SUCH AN EVENT IF IT WERE TO RECUR. THIS RECORD HAS BEEN DEEMED 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 IFU FOR PIC IX C.03 CONTAINS UPDATED LABELING REGARDING CAREGROUPS AND INTENDED USE.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ONE OF THE PIICS IN NICU THE BEDSIDES ARE ALARMS AT THE CENTRAL BUT NOT AT THE BEDSIDE. BED-TO-BED OVERVIEW IS NOT WORKING PROPERLY IN THE NICU UNIT. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493574 PIC IX HARDWARE PIC IX HARDWARE MHX PHILIPS MEDICAL SYSTEMS 866424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown