BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 23235999 · Received October 7, 2025

    Report

    Report Number
    9610816-2025-000917
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 7, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    PMA / PMN Number
    K211900
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 REPORTING INSTITUTION PHONE NUMBER: (B)(6). ANALYSIS WAS PERFORMED BY THE REMOTE SERVICE ENGINEER (RSE) AND CLINICAL APPLICATION SPECIALIST (CAS), WHO REVIEWED THE LOG FILES AND STRIPS. TELEMETRY WAS FOUND TO BE FUNCTIONAL, NO DEVICE MALFUNCTION DETECTED. THE CAS SUSPECTED ECG SIGNAL QUALITY ISSUES, FOR WHICH EDUCATION WAS PROVIDED TO THE CUSTOMER ON HOW TO IMPROVE THIS SIGNAL QUALITY. MEDICAL SAFETY REVIEW OF THE STRIPS IDENTIFIED THE ST/AR ALGORITHM COMPARES THE PATIENT'S DOMINANT "NORMAL" BEAT WITH INCOMING BEATS TO MATCH. IT EXPECTS A VENTRICULAR BEAT TO BE WIDER AND TO LOOK DIFFERENT FROM THE "NORMAL" BEAT. IN THIS CASE, IF YOU LOOK AT THE BEATS BEFORE THE RUN, AND COMPARE WITH THE BEATS DURING THE EVENT, THEY ARE VERY SIMILAR. HENCE WHY THE ALGORITHM WILL CONSIDER THESE BEATS ARE OTHERWISE "NORMAL" BUT EARLIER THAN EXPECTED, LEADING TO THE SUPRAVENTRICULAR OR "S" CLASSIFICATION.' THE RESULTS OF THE ANALYSIS INDICATE THERE DOES NOT APPEAR TO BE ANY MALFUNCTION; HOWEVER, IT CANNOT BE DETERMINED WHETHER THE DEVICE CAUSED OR CONTRIBUTED AN EVENT. BASED ON THE RESULTS OF THE ANALYSIS, THE PRODUCT WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND THE CAUSE OF THE REPORTED PROBLEM IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THE TELEMETRY DEVICE LOST CONNECTION TO THE CENTRAL STATION, DURING WHICH TIME THE PATIENT DEVELOPED VENTRICULAR TACHYCARDIA. THE PATIENT WAS IN THE RESTROOM AT THE TIME OF THE REPORTED LOST CONNECTION. NURSING STAFF DETERMINED THE ARRYTHMIA HAD OCCURRED WHEN CHECKING RHYTHM STRIPS AFTER THE ISSUE HAD OCCURRED. CLINICAL APPLICATION REVIEWED THE LOGS AND RHYTHM STRIPS, REVEALING TELEMETRY WAS FUNCTIONAL WITH NO MALFUNCTION DETECTED. THE CENTRAL STATION DID NOT ALARM FOR VENTRICULAR TACHYCARDIA DUE TO SUSPECTED ECG SIGNAL QUALITY ISSUES, FOR WHICH EDUCATION WAS PROVIDED TO THE CUSTOMER ON HOW TO IMPROVE THIS SIGNAL QUALITY. THERE WAS NO REPORT OF ACTUAL HARM OR PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440463 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other