BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21623671 · Received March 17, 2025

    Report

    Report Number
    9610816-2025-000225
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 14, 2025
    Report Date
    May 13, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838122772
    PMA / PMN Number
    K211900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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. SECTION E REPORTING INSTITUTION PHONE #: (B)(6).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION AND THE RESULTS INDICATE THAT THE NON-INVASIVE BLOOD PRESSURE (NBP) ALARMS WERE OFF FROM 13:42:44 UNTIL 20:49:11 ON FEBRUARY 14TH, 2025. SINCE THE ALARMS FOR NBP WERE OFF, NO ALARM COULD BE GENERATED FOR THE NBP MEASUREMENT AT 19:00. SEE LOG EXCERPT BELOW: 14.2.2025 13.42.44 OYS; B5-573; NBP - ALERTS BETWEEN IN USE-OFF; MX850-S011. 14.2.2025 20.49.11 OYS; B5-573; NBP - ALERTS BETWEEN OFF-IN USE; MX850-S011. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE DEVICE WAS WORKING AS DESIGNED AND CONFIGURED. THE REPORTED PROBLEM WAS NOT CONFIRMED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6), AROUND 19 O'CLOCK, THE SURVEILLANCE WAS NOT ALARMING ABOUT BLOOD PRESSURE. 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
    1565853 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 866389 00884838122772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown