BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21110282 · Received January 9, 2025

    Report

    Report Number
    1218950-2025-000015
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 12, 2024
    Report Date
    February 12, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838121782
    PMA / PMN Number
    K211900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS REPORTED UNDER INCORRECT REGISTRATION NUMBER, PLEASE REFER TO 9610816-2025-000119 FOR FURTHER INFORMATION REGARDING THIS COMPLAINT. A PHILIPS TECHNICAL CONSULTANT (TC) WENT TO THE CUSTOMER SITE TO EVALUATE THE REPORTED ISSUE. THE TC REVIEWED THE CLINICAL AUDIT LOGS AND FOUND THAT THE SYSTEM WAS PROVIDING AN INOP AND SOUND PLAYED AS INTENDED DURING THE SUGGESTED TIMEFRAME. THE LOGS ALSO SHOW THAT SOMEONE WAS ACKNOWLEDGING THE ALARMS FROM THE PIC IX. ADDITIONAL TESTING WAS PERFORMED TO CONFIRM "ECG LEADS OFF" INOP ALARMING WAS FUNCTIONING AS DESIGNED. IT WAS DETERMINED THAT THE SYSTEM WAS FUNCTIONING AS INTENDED DURING THE SUGGESTED TIMEFRAME AND ALARMS WERE BEING PHYSICALLY ACKNOWLEDGING. ADDITIONAL TESTING CONFIRMED THE "ECG LEADS OFF" INOP ALARMING WAS FUNCTIONING AS DESIGNED.

    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

    IT WAS REPORTED THAT THE PIC IX IS NOT SYSTEM IS NOT ALARMING FOR "LEADS OFF". THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PIC IX IS NOT SYSTEM IS NOT ALARMING. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325142 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866389 00884838121782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown