BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 19105591 · Received April 15, 2024

    Report

    Report Number
    1218950-2024-00259
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 21, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K153702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    A PHILIPS NETWORK ENGINEER REVIEWED LOGS AND INDICATED A LOT OF MACFLAP IN THE LOGS, WHICH USUALLY INDICATES A LOOP. UNIDIRECTIONAL LINKS ARE A COMMON CAUSE OF A BRIDGING LOOP. ON FIBER LINKS, A FAILURE THAT GOES WITHOUT DETECTION OFTEN CAUSES UNIDIRECTIONAL LINKS. ANOTHER CAUSE IS A PROBLEM WITH A TRANSCEIVER. ANYTHING THAT CAN LEAD A LINK TO STAY UP AND PROVIDE A ONE-WAY COMMUNICATION IS VERY DANGEROUS WITH REGARD TO STP. A PHILIPS PRODUCT SURVEILLANCE ENGINEER ALSO REVIEWED THE ISSUE AND PROVIDED THE FOLLOWING: THE ALLEGATION IS ATTRIBUTABLE TO NETWORK RELIABILITY CONCERNS AND NOT INDICATIVE OF A FLAW WITHIN THE PHILIPS INFORMATION CENTER. ( PHILIPS PRODUCTS ARE WORKING AS DESIGNED). PHILIPS MEDICAL EQUIPMENT HAS BEEN ENGINEERED TO MEET STRINGENT STANDARDS OF PERFORMANCE AND RELIABILITY. HOWEVER, THE EFFECTIVENESS OF THESE SYSTEMS IS CONTINGENT UPON THE STABILITY AND FUNCTIONALITY OF THE SUPPORTING NETWORK INFRASTRUCTURE. THIS ALLEGATION IS DIRECTLY RELATED TO NETWORK STABILITY. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS NON-CISCO SFP MODULES INSTALLED PREVIOUSLY BY THE CUSTOMER. THE SFP MODULES ARE INSERTED IN THE SWITCHES TO ACCOMMODATE COPPER OR FIBER CONNECTIONS IN THE UPLINK PORTS. THE REPORTED PROBLEM WAS CONFIRMED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A GLOBAL ERROR OCCUR ON ALL SWITCHES, CONNECTIVITY CRITICAL : SWITCH UNREACHABLE, STARTING AT THU 3/21/2024 11:17 AM ON THE PHILIPS NETWORK.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING A GLOBAL ERROR OCCUR ON ALL SWITCHES, SWITCH UNREACHABLE. THE DEVICE WAS IN CLINICAL USE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412885 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown