BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 12508982 · Received September 21, 2021

    Report

    Report Number
    1218950-2021-10950
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    September 15, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT EXPERIENCED CARDIAC ARRHYTHMIAS (TACHYCARDIA, BRADYCARDIA, AND ASYSTOLE IN SUCCESSION). AS THE PATIENT WAS IN GENERALLY CRITICAL CONDITION, SEVERAL OF THE CLINICAL STAFF AND A DOCTOR WERE IN THE ROOM WITH THEM. UP UNTIL THAT POINT, THE ALARM SYSTEM WORKED BOTH IN THE ROOM AND AT THE PIC IX. WHILE A NURSE WAS PREPARING MEDICATION FOR THE PATIENT, THE PIC IX STARTED TO ¿SHUT DOWN¿ SEVERAL TIMES IN SUCCESSION (FROM ABOUT 01:10AM ONWARD). AFTER SOME TIME, THE PATIENT WAS STABILIZED, AND THE MEDICAL STAFF WITHDREW FROM THE ROOM. THE PATIENT THEN EXPERIENCED ANOTHER ASYSTOLE EVENT. THE ALARM WAS ONLY DISPLAYED ON THE BEDSIDE MONITOR OF THE PATIENT¿S ROOM, AND NOT TRANSMITTED TO THE PIC IX AS IT HAD SHUT DOWN AGAIN. FURTHER, THE MOBILE ALARM FORWARDING WAS SUSPENDED AT THAT TIME DUE TO TECHNICAL PROBLEMS. THERE WAS AT LEAST ONE NURSE IN THE PATIENT¿S ROOM AT ALL TIME WHO NOTICED THE ALARMS AND INTERVENED ACCORDINGLY. THE NURSE PRESSED THE RESUSCITATION BUTTON AND SHOUTED FOR HELP TO MAKE THE DOCTOR AWARE OF THE EMERGENCY. THE DOCTOR WAS THEN BACK IN THE ROOM IMMEDIATELY AFTER THE ALARM WAS TRIGGERED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE BIOMED AND CONFIRMED THE PROBLEM. THE RSE THEN ANALYZED THE LOGS AND PERFORMED TROUBLESHOOTING ON THE PERIPHERALS (FIREWALL, SWITCHES, ETC.) SHOWED NO ERROR. THE RSE ADVISED THE CUSTOMER, VIA EMAIL THAT THERE ARE NETWORK ISSUES AND THAT THEY SHOULD SPEAK WITH THEIR LOCAL INFORMATION TECHNOLOGY (IT) STAFF AS THE CUSTOMER¿S NETWORK IS A CUSTOMER SUPPLIED CLINICAL NETWORK (CSCN). THE ISSUE WAS ALSO ESCALATED TO A PHILIPS NATIONAL SUPPORT SPECIALIST (NSS). THE NSS DETERMINED THE CUSTOMER¿S NETWORK WAS HYBRID, INCLUDING BOTH THE CSCN AND A PHILIPS SUPPLIED CLINICAL NETWORK (PSCN). THE CONNECTION OF THE SURVEILLANCES TO THE PHYSIO AND PRI SERVERS IS LOST, WHICH LEADS TO AN APPLICATION RESTART. THE NSS FURTHER DETERMINED THAT THE ISSUE WAS RELATED TO AN INCONSISTENT NETWORK CONFIGURATION. THE NSS RECOMMENDED THE FOLLOWING TO THE CUSTOMER: ROUTER A SHOULD HAVE THE LOWEST SPANNING TREE PRIORITY (4096). ROUTER B SHOULD HAVE A SPANNING TREE PRIORITY FOR ALL VIRTUAL LOCAL AREA NETWORKS (VLAN) OF 8192. VLAN300 SHOULD BE CONFIGURED ON AT LEAST AN ADDITIONAL DISTRIBUTION PAIR, AND ALLOW THE VLAN ON THE TRUNK INTERFACES TO THE SWITCHES. ENSURE THAT ALL SWITCHES CAN BE TIME SYNCHRONIZED WITH THE CUSTOMER NETWORK TIME PROTOCOL (NTP) SERVER, TO ENSURE CONSISTENT LOGGING AND COMPARABLE TIMESTAMPS BETWEEN THE PIC IX AND THE NETWORK INFRASTRUCTURE. NO DEVICE MALFUNCTION OCCURRED. THE CUSTOMER'S PROBLEM WAS FOUND TO BE DUE TO AN INCONSISTENT NETWORK CONFIGURATION. THIS WAS RESOLVED BY THE NSS RECOMMENDING CONFIGURATION CHANGES TO MAKE, WHICH STABILIZED THE NETWORK. IT WAS ALSO DISCOVERED THAT THE FACILITY HAD A BAD FIBER CONNECTION, AND THAT THEY WOULD NEED TO RESOLVE THAT AS WELL. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 0

    THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT DURING ONGOING NETWORKING ISSUES INVOLVING THEIR PHILIPS INFORMATION CENTER IX (PIC IX) SYSTEM, A PATIENT REQUIRED REANIMATION/RESUSCITATION DURING A RECONNECTION OF THE PIC IX CENTRAL STATION.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING ONGOING NETWORKING ISSUES INVOLVING THEIR PHILIPS INFORMATION CENTER IX (PIC IX) SYSTEM, A PATIENT REQUIRED REANIMATION/ RESUSCITATION DURING A RECONNECTION OF THE PIC IX CENTRAL STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406589 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention