BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIIC CLASSIC UPGRADE

    MDR report key: 18573988 · Received January 24, 2024

    Report

    Report Number
    1218950-2024-00052
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    December 30, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K081983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE BIOMED REPORTED THAT THREE STATIONS ARE RUNNING IN LOCAL MODE. A PHILIPS REMOTE SERVICE SPECIALIST (RSS) SPOKE WITH THE CUSTOMER BIOMED AND SUGGESTED THAT HE CHECK THE DATA CLOSET FOR ANY DOWN UPS OR NETWORK DEVICES. A PHILIPS TECHNICAL CONSULTANT (TC) WAS DISPATCHED AND WAS ABLE TO ACCESS THE CUSTOMER DATABASE SERVER (DBS). THE TC DISCOVERED THAT THE HOST WAS IN RECONNECT MODE DUE TO THE HOST RESTARTING. THIS ISSUE WAS CAUSED BY MEMORY BOTTLENECK LOGS. THE REPORTED PROBLEM WAS CONFIRMED. RECONNECTING TO MONITORING REMOVED THE BANNER ON THE HOST STATION. THE TC RECOMMENDED THAT THE CUSTOMER UPGRADE THEIR SYSTEM TO PREVENT SYSTEM DOWNTIME IF ANOTHER ISSUE OCCURS. THE DEVICE IS OPERATIONAL AND REMAINS IN USE.

    Additional Manufacturer Narrative · 0

    PRODUCT BRAND NAME: PIIC CLASSIC UPGRADE COMMON DEVICE NAME: PIIC CLASSIC UPGRADE MODEL NUMBER: 866117. CATALOG ITEM IDENTIFIER 866117. 510K: K081983.

    Description of Event or Problem · 0

    THERE IS A BANNER AT THE TOP OF MONITOR GIVING ERROR MESSAGE, "GATEWAY DISCONNECTED FROM DATABASE". THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED. THE BIOMED REPORTED THAT THREE STATIONS ARE RUNNING IN LOCAL MODE. A PHILIPS REMOTE SERVICE SPECIALIST (RSS) SPOKE WITH THE CUSTOMER BIOMED AND SUGGESTED HIM TO CHECK THE DATA CLOSET FOR ANY DOWN UPS OR NETWORK DEVICES. A PHILIPS TECHNICAL CONSULTANT (TC) WAS DISPATCHED AND WAS ABLE TO ACCESS THE CUSTOMER DATABASE SERVER (DBS). THE TC DISCOVERED THAT THE HOST WAS IN RECONNECT MODE DUE TO THE HOST RESTARTING. THIS ISSUE WAS CAUSED BY MEMORY BOTTLENECK LOGS. RECONNECTING TO MONITORING REMOVED THE BANNER ON THE HOST STATION. THE TC RECOMMENDED THAT THE CUSTOMER UPGRADE THEIR SYSTEM TO PREVENT SYSTEM DOWNTIME IF ANOTHER ISSUE OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140662 PIIC CLASSIC UPGRADE PIIC CLASSIC UPGRADE MHX PHILIPS MEDICAL SYSTEMS 866117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown