BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21622890 · Received March 17, 2025

    Report

    Report Number
    9610816-2025-000224
    Event Type
    Malfunction
    Date Received
    March 17, 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. THE CUSTOMER REPORTED 4 TOTAL EVENTS WHERE LOW OR HIGH BLOOD PRESSURE WAS NOT ALARMED. THE EVENT DATE FOR THIS ISSUE IS CURRENTLY UNKNOWN AND PENDING GOOD FAITH EFFORT (GFE) ATTEMPTS. 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 MULTIPLE TIMES BETWEEN (B)(6). SEE EXCERPT OF THE LOGS BELOW: (B)(6) 2025 17.00.45 OYS B5-571 SECTOR: NBPS 86 <90 GIVEN AT 17.00.40. PIC IX: B5STEVAIX. (B)(6) 2025 17.00.45 OYS B5-571 NBPS 86 <90 GIVEN AT 17.00.40. MX850-S010. (B)(6) 2025 20.01.17 OYS B5-571 SECTOR: NBPK 122 >110 GIVEN AT 20.01.12. PIC IX: B5STEVAIX. (B)(6) 2025 20.01.17 OYS B5-571 NBPK 122 >110 ISSUED AT 20.01.12. MX850-S010. (B)(6) 2025 22.01.01 OYS B5-571 NBPK 39 <60 ISSUED AT 22.00.59. MX850-S010. (B)(6) 2025 22.01.02 OYS B5-571 SECTOR: NBPK 39 <60 ISSUED AT 22.00.59. PIC IX: B5STEVAIX. (B)(6) 2025 22.04.18 OYS B5-571 SECTOR: NBPS 83 <90 ISSUED AT 22.04.15. PIC IX: B5STEVAIX. (B)(6) 2025 22.04.18 OYS B5-571 NBPS 83 <90 ISSUED AT 22.04.15. MX850-S010. (B)(6) 2025 23.00.34 OYS B5-571 NBPS 85 <90 ISSUED AT 23.00.30. MX850-S010. (B)(6) 2025 23.00.35 OYS B5-571 SECTOR: NBPS 85 <90 ISSUED AT 23.00.30. PIC IX: B5STEVAIX. (B)(6) 2025 02.01.16 OYS B5-571 NBP FAILED GIVEN AT 02.01.12. MX850-S010. (B)(6) 2025 02.01.17 OYS B5-571 SECTOR: NBP FAILED GIVEN AT 02.01.12. PIC IX: B5STEVAIX. (B)(6) 2025 04.00.45 OYS B5-571 SECTOR: NBPK 49 <60 GIVEN AT 04.00.42. PIC IX: B5STEVAIX. (B)(6) 2025 04.00.45 OYS B5-571 NBPK 49 <60 GIVEN AT 04.00.42. MX850-S010. (B)(6) 2025 04.05.40 OYS B5-571 SECTOR: NBPS 83 <90 ISSUED AT 04.05.37. PIC IX: B5STEVAIX. (B)(6) 2025 04.05.40 OYS B5-571 NBPS 83 <90 ISSUED AT 04.05.37. MX850-S010. (B)(6) 2025 05.00.42 OYS B5-571 NBPK 59 <60 ISSUED AT 05.00.38. MX850-S010. (B)(6) 2025 05.00.43 OYS B5-571 SECTOR: NBPK 59 <60 ISSUED AT 05.00.38. PIC IX: B5STEVAIX. (B)(6) 2025 06.00.35 OYS B5-571 NBPK 53 <60 GIVEN AT 06.00.35. MX850-S010. (B)(6) 2025 06.00.36 OYS B5-571 SECTOR: NBPK 53 <60 GIVEN AT 06.00.35. PIC IX: B5STEVAIX. (B)(6) 2025 06.05.15 OYS B5-571 NBPS 80 <90 GIVEN AT 06.05.14. MX850-S010. (B)(6) 2025 06.05.16 OYS B5-571 SECTOR: NBPS 80 <90 GIVEN AT 06.05.14. PIC IX: B5STEVAIX. 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 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 6:00 AM, BED B5-571 DID NOT ALARM FOR 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
    1210255 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