BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 23267722 · Received October 10, 2025

    Report

    Report Number
    1218950-2025-000593
    Event Type
    Death
    Date Received
    October 10, 2025
    Date of Event
    August 20, 2025
    Report Date
    November 5, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K163584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INVOLVEMENT WAS REPORTED, THE PATIENT EXPERIENCED A BRADYCARDIA EVENT. PATIENT HAD PASSED AWAY. A PHILIPS REMOTE CLINICAL SUPPORT (RCS) SPOKE WITH THE CUSTOMER TELE TECHNICIAN WHO ASKED TO GET SOME DATA ON A PATIENT THAT WAS DISCHARGED FROM THE HOSPITAL IN AUGUST. THE CUSTOMER ORIGINALLY DENIED ANY PATIENT DEATH OR INJURY AND STATED THEY WERE DISCHARGED AND THEY JUST NEED SOME INFORMATION. THE RCS WAS PROVIDED THE INFORMATION TO REMOTE INTO THE CUSTOMER'S PRIMARY SERVER. THE INFORMATION PROVIDED INDICATED THAT THIS PATIENT LOOKED AS THOUGH THEY PASSED AWAY. THE RCS COULD NOT EXPORT THE CLINICAL AUDIT LOGS BUT WAS ABLE TO RETRIEVE SCREEN SHOTS TO SHARE WITH THE CUSTOMER CLINICAL MANAGER. SEVERAL ATTEMPTS WERE MADE TO REACH OUT TO THE CUSTOMER CLINICAL MANAGER WITH NO RESPONSE. THE RCS WAS ADVISED TO CONTACT THE FLOOR NURSE TO REVIEW THE CLINICAL AUDIT FINDINGS. THE CUSTOMER WAS ADVISED THAT THE PATIENT WAS ADMITTED (B)(6) AND THEY WERE PLACED ON TELEMETRY BOX MXT101. FROM THAT TIME UNTIL THE PATIENT EXPIRED, THERE WAS NEVER ANY SIGN OF NORMAL RHYTHM. IT APPEARED AS THOUGH THE PATIENT WAS IN SOME TYPE OF DISTRESS FROM THE TIME THEY WERE ADMITTED. THE RCS FOLLOWED UP WITH EMAILS TO THE CLINICAL MANAGER AND FLOOR NURSE PROVIDING SCREENSHOTS OF THE AUDIT LOGS AT TIMES THEY REQUESTED. THE LOGS WERE REVIEWED WITH NO MALFUNCTION FOUND. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THE CUSTOMER WAS ALSO ADVISED TO REACH OUT WITH ANY MORE QUESTIONS. THE RCS MADE ATTEMPTS TO FOLLOW UP WITH THE CUSTOMER, BUT THE CUSTOMER WAS ONLY GOING TO CALL BACK WITH ANY QUESTIONS ABOUT AUDIT DATA. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE CUSTOMER WAS REQUESTING DATA REGARDING A PATIENT INCIDENT; THERE WAS NO ALLEGATION OR CONFIRMATION OF MALFUNCTION OF THE DEVICE. SEVERAL ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER FOR ADDITIONAL INFORMATION, BUT THE CUSTOMER HAS NOT RESPONDED, AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. BASED ON THE INFORMATION PROVIDED THERE WAS NO MALFUNCTION OF THE DEVICE AND THE DEVICE WAS FUNCTIONING AS DESIGNED. 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 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.

    Description of Event or Problem · 0

    EVENT: IT WAS REPORTED THE CUSTOMER REQUESTED ASSISTANCE OBTAINING INFORMATION AFTER THE PATIENT HAD BEEN DISCHARGED FROM THE SYSTEM AFTER PASSING AWAY. THE CUSTOMER SPECIFICALLY WANTED TO KNOW WHAT OCCURRED PRIOR TO A BRADYCARDIA ALARM ON (B)(6) 2025 AND WHETHER THE PATIENT HAD A NORMAL RHYTHM AT ANY POINT. THE PATIENT WAS ADMITTED ON (B)(6) 2025 AND CONNECTED TO TELEMETRY. FROM THAT TIME UNTIL THE PATIENT PASSED AWAY THERE WAS NO SIGN OF A NORMAL RHYTHM, APPEARING AS IF THE PATIENT WAS IN DISTRESS FROM THE TIME OF ADMISSION. THE CENTRAL STATION ALONG WITH LOGS WERE TESTED AND REVIEWED WITH NO MALFUNCTION FOUND. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1935054 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death