BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 23096278 · Received September 19, 2025

    Report

    Report Number
    9610816-2025-000844
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 30, 2025
    Report Date
    September 19, 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
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND WENT ONSITE. THE FSE COLLECTED THE INTELLIVUE PATENT MONITOR (IVPM) CONFIGURATION FILES, LOGS AND TREND DATA, AS WELL THE PIC IX CLINICAL AUDIT LOGS AND PERFORMED A FUNCTION CHECK ON ALL AFFECTED DEVICES. THE FSE MET WITH THE CUSTOMER BIOMED AND CONFIRMED UNIT AND ROOM WHERE PATIENT WAS DURING THE INCIDENT. THE RELATED BED LABEL IS DM5201 AND DEVICE LABEL IS DMXS5-2-12. THE BIOMED WHO ADVISED THAT THERE IS NO TECHNICAL ISSUES WITH THE PIC IX PC OR SPEAKER. THE FSE CHECKED THE PIC IX UNIT IN ROOM NUMBER 5200 AND CONFIRMED THE PIC IX SYSTEM AND THE SPEAKER WAS WORKING AS EXPECTED. ON THE CLINICAL AUDIT TRAIL FOR THE AFFECTED BED LABEL THE FSE COULD FIND THE ENTRY FOR 02:52 AM, (B)(6) 2025: PIC IX IN ROOM NUMBER 5200, *VENT RHYTHM GENERATED 02:52:17 AM ON DMX5-2-12/ENDED 02:55 AM. THAT SHOW THE VENT RHYTHM AND RED ALARMS TIMES DID OCCUR BETWEEN 2:52:21 AM AND 2:55:22 AM. (B)(6) 2025 AT 2:52:21 VENT RHYTHM GENERATED ON MONITOR DMXS5-2-12. (B)(6) 2025 AT 2:52:22 VENT RHYTHM GENERATED ON PIC IX: CE-DRHTELEOV3. (B)(6) 2025 AT 2:52:47 RED ALARM SOUNDED ON THE PIC IX: CE-DRHTELEOV3. (B)(6) 2025 AT 2:53:44 ALARM STOPPED ON PIC IX: CE-DRHTELEOV3. (B)(6) 2025 AT 2:55:16 RED ALARM SOUNDED ON THE PIC IX: CE-DRHTELEOV3. (B)(6) 2025AT 2:55:22 VENT RHYTHM ENDED ON MONITOR DMXS5-2-12. (B)(6) 2025 AT 2:55:22 VENT RHYTHM ENDED ON PIC IX: CE-DRHTELEOV3. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION TO THE PRODUCT SUPPORT ENGINEER (PSE) AND THE RESULTS OF THE ANALYSIS INDICATE THAT FROM THE AUDIT LOG, THE PSE CAN SEE THE RED ALARM OCCURRING AT 02:52 ON BOTH THE BEDSIDE MONITOR AND ON THE PIC IX. (B)(6) 2025 02:53:44 (B)(6) HOSPITAL 5201 SECTOR: ***XBRADY 28 <30 ENDED. PIC IX: CE-DRHTELEOV3 RED ALARM (B)(6) 2025 02:53:43 (B)(6) HOSPITAL 5201 ***XBRADY 28 <30 ENDED. DM5201 RED ALARM (B)(6) 2025 02:52:47 (B)(6) HOSPITAL 5201 SECTOR: ***XBRADY 29 <30 GENERATED AT 02:52:45. PIC IX: CE-DRHTELEOV3 RED ALARM (B)(6) 2025 02:52:46 (B)(6) HOSPITAL 5201 ***XBRADY 29 <30 GENERATED AT 02:52:45. DM5201 RED ALARM AS WELL THE PSE SEE THE MONITOR GOING TO STANDBY AND THEN EXITING OUT OF STANDBY IMMEDIATELY, BUT THE ALARM SHOULD HAVE SOUNDED. (B)(6) 2025 02:54:45 (B)(6) HOSPITAL 5201 RESUME ALL ALARMS DM5201 RESUME ALL ALARMS (B)(6) 2025 02:54:45 (B)(6) HOSPITAL 5201 **HR 32 <35 GENERATED AT 02:54:44. DM5201 YELLOW ALARM (B)(6) 2025 02:54:22 ALARM OR INOP SOUND STOPPED. PIC IX: CE-DRHTELEOV3 ALERT SOUND (B)(6) 2025 02:54:17 INOP SOUND PLAYED. PIC IX: CE-DRHTELEOV3 ALERT SOUND 30.08.2025 02:53:44 (B)(6) HOSPITAL 5201 ECG - ECG FROM OFF TO ON DM5201 MEASUREMENT ON/OFF (B)(6) 2025 02:53:44 ALARM OR INOP SOUND STOPPED. PIC IX: CE-DRHTELEOV3 ALERT SOUND (B)(6) 2025 02:53:44 (B)(6) HOSPITAL 5201 SECTOR: ***XBRADY 28 <30 ENDED. PIC IX: CE-DRHTELEOV3 RED ALARM (B)(6) 2025 02:53:43 (B)(6) HOSPITAL 5201 ECG - ECG FROM ON TO OFF DM5201 MEASUREMENT ON/OFF (B)(6) 2025 02:53:43 (B)(6) HOSPITAL 5201 PAUSE ALL ALARMS DM5201 PAUSE ALL ALARMS (B)(6) 2025 02:53:43 (B)(6) HOSPITAL 5201 ***XBRADY 28 <30 ENDED. DM5201 RED ALARM (B)(6) 2025 02:53:42 (B)(6) HOSPITAL 5201 EXITING STANDBY DM5201 EXITING STANDBY (B)(6) 2025 02:53:42 (B)(6) HOSPITAL 5201 RESUME REQUESTED FROM: MANAGE PATIENT. DM5201, 5200MO4X2 EXITING STANDBY (B)(6) 2025 02:53:41 (B)(6) HOSPITAL 5201 ENTERING STANDBY DM5201 ENTERING STANDBY (B)(6) 2025 02:53:41 (B)(6) HOSPITAL 5201 STANDBY REQUESTED FROM: MANAGE PATIENT. DM5201 ENTERING STANDBY (B)(6) 2025 02:53:14 (B)(6) HOSPITAL 5202 SECTOR: CANNOT ANALYZE ECG ENDED. PIC IX: CE-DRHTELEOV3 LOGGED INOP (B)(6) 2025 02:52:47 RED ALARM SOUND PLAYED. PIC IX: CE-DRHTELEOV3 ALERT SOUND (B)(6) 2025 02:52:47 (B)(6) HOSPITAL 5201 SECTOR: ***XBRADY 29 <30 GENERATED AT 02:52:45. PIC IX: CE-DRHTELEOV3 RED ALARM (B)(6) 2025 02:52:47 (B)(6) HOSPITAL 5201 SECTOR: **HR 30 <35 ENDED. PIC IX: CE-DRHTELEOV3 YELLOW ALARM (B)(6) 2025 02:52:46 (B)(6) HOSPITAL 5201 **HR 30 <35 ENDED. DM5201 YELLOW ALARM (B)(6) 2025 02:52:46 (B)(6) HOSPITAL 5201 ***XBRADY 29 <30 GENERATED AT 02:52:45. DM5201 RED ALARM (B)(6) 2025 02:52:39 (B)(6) HOSPITAL 5202 SECTOR: CANNOT ANALYZE ECG GENERATED AT 02:52:35. PIC IX: CE-DRHTELEOV3 LOGGED INOP (B)(6) 2025 02:52:38 YELLOW ALARM SOUND PLAYED. PIC IX: CE-DRHTELEOV3 ALERT SOUND (B)(6) 2025 02:52:32 INOP SOUND PLAYED. PIC IX: CE-DRHTELEOV3 ALERT SOUND (B)(6) 2025 02:52:27 ALARM OR INOP SOUND STOPPED. PIC IX: CE-DRHTELEOV3 ALERT SOUND (B)(6) 2025 02:52:22 YELLOW ALARM SOUND PLAYED. PIC IX: CE-DRHTELEOV3 ALERT SOUND (B)(6) 2025 02:52:22 (B)(6) HOSPITAL 5200 SECTOR: * VENT RHYTHM GENERATED AT 02:52:17. PIC IX: CE-DRHTELEOV3 YELLOW ALARM (B)(6) 2025 02:52:21 (B)(6) HOSPITAL 5200 * VENT RHYTHM GENERATED AT 02:52:17. DMX5-2-12 YELLOW ALARM. BASED ON THE ANALYSIS FINDINGS THE DEVICE WAS WORKING TO ITS SPECIFICATION WITH NO FAILURES FOUND. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE CONFIRMED. THE REPORTED PROBLEM WAS NOT CONFIRMED. ANALYSIS WAS PERFORMED AND INVESTIGATION HAS BEEN COMPLETED. THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT INFORMATION CENTER IX IN ROOM NUMBER 5200 DID NOT ALARM FOR A RED V-TACH ALARM FOR A CONNECTED MX40 PATIENT WORN/BEDSIDE MONITOR ON (B)(6) 2025 AT AROUND 02:52 AM. THE DEVICE WAS IN CLINICAL USE. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397913 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX 00884838122772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown