BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 20347755 · Received October 1, 2024

    Report

    Report Number
    1218950-2024-00700
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 18, 2024
    Report Date
    November 12, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. BOX E: REPORTER PHONE #: (B)(6).

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) PERFORMED AN INVESTIGATION. ANALYSIS OF LOGS DID NOT REVEAL A TECHNICAL DEFECT IN THE INFRASTRUCTURE. IN THE LOGS, THE ALARMS ARE INDICATED IN THE CORRECT ROOMS AND NO ERRORS ARE VISIBLE. WHEN VIEWING ROOM ALARM REVIEWS AT THE WEB REVIEW LEVEL, THE ALARMS ARE IN THE GOOD ROOM REVIEWS. THE REVIEWS AT THE CARE POST LEVEL DO NOT CORRESPOND TO THE REVIEWS DISPLAYED IN THE WEB REVIEW. THE REGISTRATION OF REVIEWS IS ONLY BAD AT THE CENTRAL LEVEL (PIC IX). THIS CENTRAL IS NOT IN THE SAME SOFTWARE REVISION AS THE REST OF THE INFRASTRUCTURE, WHICH IS IN C.03.08. THE PROBLEM APPEARS TO BE RELATED TO AN INCOMPATIBILITY BETWEEN THE SOFTWARE VERSION C.03.06 AND THE C.03.08 VERSION. THE PROBLEMATIC CENTRAL WAS PATCHED WITH C.03.08 SO THAT THE ENTIRE INFRASTRUCTURE WAS HOMOGENEOUS. FOLLOWING THE PATCH, THE CUSTOMER WAS ASKED TO CONTACT US AGAIN IN CASE OF A RECURRENCE OF THE PHENOMENON. NO FURTHER CALLS WERE RECEIVED. THE DEVICE WAS OPERATIONAL AFTER UPGRADING THE SOFTWARE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON AN PATIENT INFORMATION CENTER IX (PIC IX) INDICATING THAT DURING PRINTING OF THE EVENTS FOR ONE MINUTE FOR A MAR PATIENT, A BRADYCARDIA ALARM WAS INDICATED, ALTHOUGH THE TRACING DOES NOT INDICATE ANY PROBLEM. THE CARDIAC TRACING OF A COU PATIENT, LOCATED IN A NEARBY ROOM, DID INDICATE A PROBLEM; THIS PATIENT HAD BRADYCARDIA IN FRONT OF THE NURSE AND THE PRINTOUT SHOWS INDEED THE PROBLEM, BUT THE ALARM IS NOT INDICATED. THEREFORE, THE ALARM WAS INVERTED BETWEEN TWO PATIENTS ON THE SAME CENTRAL UNIT. A NURSE WAS PRESENT IN THE ROOM; THEREFORE, ANY INCIDENT WAS AVOIDED. ACTIONS WERE TAKEN AT THE HOSPITAL TO TAKE CARE OF THE PATIENT BY INCREASED MONITORING BY THE NURSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161919 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown