BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 21949518 · Received May 2, 2025

    Report

    Report Number
    9610816-2025-000366
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 5, 2025
    Report Date
    May 2, 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 EVENT WAS CONFORMED TO BE (B)(6) 2025 AT 10.37.48, PATIENT BED (B)(6)-LOCATION. THE REMOTE SERVICE ENGINEER (RSE) CHECKED THE LOG FILES WITH A CLINICAL APPLICATION SPECIALIST. IT WAS CONFIRMED THAT A FOUR SECOND LENGTH PAUSE WAS NOT DETECTED AND THUS, SYSTEM ONLY ALARMED ABOUT THE PAUSE WHICH WAS CORRECT. A PAUSE WAS MEASURED TO BE 3.92 SECONDS AND IT WAS ALSO CONFIRMED THAT FOUR SECOND TRIGGER FOR ASYSTOLE ALARM WAS NOT CHANGED. THE SUPPORTING STRIP PRINT SHOWS THAT THE FIRST BREAK LENGTH ON THIS STRIP IS SLIGHTLY UNDER 4 SECONDS. WITH THE DEFAULT SETTINGS IN USE, THE MONITOR GIVES AN "PAUSE" ALARM. ASYSTOLE ALARM APPEARS IF THE PAUSE IS OVER 4 SECONDS LONG. THE RSE CONFIRMED THAT THE ALARM LIMITS WERE CHECKED AND WERE CORRECT, THE DEVICE WAS FUNCTIONING AS CONFIGURED. A PHILIPS PRODUCT SUPPORT ENGINEER REVIEWED THE PROVIDED LOGS AND CONFIRMED THE INVESTIGATION DONE BY THE PHILIPS APPLICATION SPECIALIST. THE GAP WAS LESS THAN 4 SECONDS LONG AND THEREFOR THE PAUSE ALARM WAS THE CORRECT ALARM TO BE ANNOUNCED. THE LOGS INDICATE THAT THE PAUSE ALARM WAS ANNOUNCED AT THE CENTRAL AS YELLOW ALARM. THIS IS THE ONE THAT ALERTED ABOUT THE PAUSE: TAUKO ANNETTU KLO 10.37.48. THE ALARM WAS THEN SILENCED AT 10:40:47 TAUKO LOPETETTU. THERE WAS ANOTHER ALARM (ARTERIAL FIBRILLATION) SHORT BEFORE ETEISVARINA ANNETTU KLO 10.37.00. (B)(6).2025 10.43.32 ALARM OR INOP BEEP STOPPED. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.43.26 A YELLOW ALARM BEEP SOUNDS. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.42.58 ALARM OR INOP BEEP STOPPED. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.41.54 A RED ALARM BEEP SOUNDS. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.40.47 OYS B5-583-1 SEKTORI: TAUKO LOPETETTU. PIC IX: B5SYDSEURIX YELLOW ALARM (B)(6).2025 10.40.47 OYS B5-583-1 TAUKO LOPETETTU. MX40-S14 YELLOW ALARM (B)(6).2025 10.40.46 ALARM OR INOP BEEP STOPPED. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.40.39 INOP AUDIO PLAYED. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.40.30 ALARM OR INOP BEEP STOPPED. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.40.25 A YELLOW ALARM BEEP SOUNDS. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.37.54 ALARM OR INOP BEEP STOPPED. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.37.49 A YELLOW ALARM BEEP SOUNDS. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6) 2025 10.37.49 OYS B5-583-1 SEKTORI: TAUKO ANNETTU KLO 10.37.48. PIC IX: B5SYDSEURIX YELLOW ALARM (B)(6) 2025 10.37.48 OYS B5-583-1 TAUKO ANNETTU KLO 10.37.48. MX40-S14 YELLOW ALARM (B)(6).2025 10.37.39 ALARM OR INOP BEEP STOPPED. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.37.33 INOP AUDIO PLAYED. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.37.06 ALARM OR INOP BEEP STOPPED. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.37.01 A YELLOW ALARM BEEP SOUNDS. PIC IX: B5SYDSEURIX ALERT SOUND (B)(6).2025 10.37.01 OYS B5-583-1 SECTOR: ATRIAL FIBRILLATION GIVEN AT 10.37.00. PIC IX: B5SYDSEURIX YELLOW ALARM (B)(6).2025 10.37.00 OYS B5-583-1 ATRIAL FIBRILLATION GIVEN AT 10.37.00. MX40-S14 YELLOW ALARM IT WAS CONFIRMED THAT THE DEVICE WAS FUNCTIONING AS CONFIGURED. THE RSE CONFIRMED THAT THE ALARM LIMITS WERE CHECKED AND WERE CORRECT, BUT DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING EXACT CONFIGURATION SETTINGS. I WAS STATED THAT DEFAULT SETTINGS WERE IN USE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED. D4: MADE SEVERAL GOOD FAITH EFFORT ATTEMPTS TO OBTAIN THE SERIAL NUMBER, BUT THE SERIAL NUMBER WAS NOT PROVIDED. E1: REPORTING INSTITUTION PHONE #(B)(6). E1: REPORTER PHONE # (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PIC IX FAILED TO ALARM FOR A ASYSTOLE ARRYTHMIA EVENT, THE ASYSTOLE WAS NOT RECOGNIZED. 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
    1309986 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