BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21572212 · Received March 11, 2025

    Report

    Report Number
    9610816-2025-000189
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 13, 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

    THE PHILIPS REMOTE SERVICE ENGINEER (RSE) CHECKED THE TECHNICAL AND CLINICAL LOG FILES WITH A HELP OF A PHILIPS CLINICAL APPLICATION SPECIALIST AND IDENTIFIED THE SURVEILLANCE ALARMED PROPERLY. 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). SECTION E REPORTER PHONE #: (B)(6).

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION, AND A PHILIPS CLINICAL PRODUCT SPECIALIST REVIEWED THE DATA AND FOUND THAT THE DEVICE ALARMED FOR THE MEAN AT 2:00.44, AND THEN, IT ALARMED FOR THE MEAN AGAIN AT 03:00.48. SEE EXCERPT OF THE LOGS BELOW: 13.2.2025 02.00.46; OYS B5-572 SECTOR: **NBPK 117 >110 ISSUED AT 02.00.44. PIC IX: B5STEVAIX. 13.2.2025 02.00.46; OYS B5-572 **NBPK 117 >110 ISSUED AT 02.00.44. MX850-S012. 13.2.2025 02.01.59; OYS B5-572 SECTOR: **NBPK 117 >110 TERMINATED. PIC IX: B5STEVAIX. 13.2.2025 02.01.59; OYS B5-572 **NBPK 117 >110 TERMINATED. MX850-S012. 13.2.2025 03.00.51; OYS B5-572 SECTOR: **NBPK 121 >110 ISSUED AT 03.00.48. PIC IX: B5STEVAIX. 13.2.2025 03.00.51; OYS B5-572 **NBPK 121 >110 ISSUED AT 03.00.48. MX850-S012. 13.2.2025 03.02.31; OYS B5-572 **NBPK 121 >110 TERMINATED. MX850-S012. THE CLINICAL PRODUCT SPECIALIST EXPLAINED THAT NON-INVASIVE BLOOD PRESSURE (NBP) IS MADE UP OF THREE NUMBERS, SYSTOLIC, DIASTOLIC AND MEAN. THE MONITOR CAN BE SET TO ALARM FROM 1, 2 OR ALL 3 NUMBERS. BELOW SHOWS THE SETTINGS AS OF 00:56:27 ON FEBRUARY 13TH: 13.2.2025 00.56.27; OYS B5-572 NBP - MIDDLE UPPER:110 MIDDLE LOWER:60 X3-L020. 13.2.2025 00.56.27; OYS B5-572 NBP - DIAST. UPPER:90 DIAST. LOWER:50 X3-L020. 13.2.2025 00.56.27; OYS B5-572 NBP - SYST. UPPER:160 SYST. LOWER:90 X3-L020. 13.2.2025 00.56.27; OYS B5-572 NBP - ALARMS ENABLED X3-L020. 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 THE NIGHT OF FEBRUARY 12TH-13TH, 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.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE PATIENT INFORMATION CENTER IX INDICATING THAT ON (B)(6) 2025, AROUND 2:00 A.M., BED B5-572 DID NOT ALARM FOR BLOOD PRESSURE. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. IT WAS INDICATED THE PATIENT WAS TREATED WITH AMLODIPINE AFTER THE EVENT AND DEVELOPED NAUSEA AND HEADACHE LATER THAT SAME NIGHT; HOWEVER, IT WAS ALREADY KNOWN THE PATIENT HAD HIGH BLOOD PRESSURE. THERE WAS NO REPORT OF ACTUAL HARM ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339900 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