BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE CC & ANESTHESIA

    MDR report key: 16841140 · Received April 29, 2023

    Report

    Report Number
    1218950-2023-00265
    Event Type
    Malfunction
    Date Received
    April 29, 2023
    Date of Event
    April 13, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXJ
    UDI-DI
    00884838085565
    PMA / PMN Number
    K100272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FUNCTIONAL ANALYSIS WAS PERFORMED AND IDENTIFIED THAT THE ISSUE IS SOLVED BY TURNING OFF THE BRAUN COMMUNICATION RACK AND TURNING IT ON AGAIN. IT SEEMS THAT THE NETWORK CARD HAD BEEN "STUCK" SOMEHOW. NETWORK CABLES IN POOR CONDITION WERE REPLACED. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION. PQM ADVISED TO CHECK WITH THE PERSON WHO REPORTED THE ISSUE AND CHECK IF THE ISSUE STILL HAPPENING OR NOT. AS PER CONFIRMATION FROM FIELD SERVICE ENGINEER, IT IS NOT KNOWN WHY THE PREVIOUS PUMPS WERE DISPLAYED IN THE APPLICATION. PUMPS ITEMS WERE REFRESHED, RESTARTING BRAUN RACK. AFTER RESTARTING, NEW PUMPS WAS DISPLAYED CORRECTLY. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS UNKNOWN. THE REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN PROCESS OF OBTAINING ADDITIONAL INFORMATION. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON INTELLISPACE CC & ANESTHESIA INDICATING THATIM961311 DOES NOT ALLOW TO ASSIGN THE PERFUSIONS THAT THEY HAVE SCHEDULED AND ASSIGNS PERFUSIONS THAT THEY HAVE NOT HAD SCHEDULED. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737808 INTELLISPACE CC & ANESTHESIA INTELLISPACE CC & ANESTHESIA DXJ PHILIPS MEDICAL SYSTEMS 866148 00884838085565

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown