BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 23983571 · Received January 6, 2026

    Report

    Report Number
    9610816-2026-100022
    Event Type
    Death
    Date Received
    January 6, 2026
    Date of Event
    November 17, 2025
    Report Date
    January 26, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    MHX
    UDI-DI
    00884838104594
    PMA / PMN Number
    K211900
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS KEY ACCOUNT MANAGER RECALLS PERFORMING DEVICE INVENTORY FOR THE HOSPITAL ON (B)(6) 2025 ON TISCH 14 WEST, WHEN A NURSE REPORTED A FEW MINUTES BEFORE HIS ONSITE ARRIVAL A PATIENT EXPIRED AT (7:15AM) WHILE BEING MONITORED ON THE UNIT. THE NURSE RECALLED THE PATIENT DESATURATED TO 30 BUT NO ALARM WAS ANNUNCIATED. THE PATIENT WAS IN TISCH 14-30, ON BED (B)(6). A GOOD FAITH EFFORT (GFE) EMAIL WENT OUT TO THE KEY ACCOUNT MANAGER INQUIRING ABOUT THE PATIENT'S CONDITION, AS WELL AS INFORMATION ABOUT THE UNIT AT THE TIME OF THE EVENT. THE GFE RESPONSE WAS UNABLE TO OBTAIN FURTHER INFORMATION. LOGS WERE SENT TO AN INTERNAL PRODUCT SUPPORT ENGINEER (PSE) FOR FURTHER ANALYSIS. SUMMARY OF TECHNICAL COMPLAINT INVESTIGATION: THE PSE INDICATED THERE WAS NOTHING ON 7:15, BUT THERE WERE INCIDENTS ON (B)(6) AT 07:23:38 AND AT 07:25:49, RED ALARMS GENERATED FOR DESAT, WHEN IT WAS 81 RESPECTIVELY 27. BUT THE ALARM WAS ACKNOWLEDGED. OVERALL, THE DESAT DID ALARM UNTIL IT WAS ACKNOWLEDGED ON THE PIC. THE PIC IS FUNCTIONING AS EXPECTED. ON (B)(6) 2025 07:26:20, (B)(6) CENTER, T1430-01 SECTOR: TELE WEAK SIGNAL GENERATED AT 07:26:13. PIC IX: TH14ESV1, LOGGED INOP. ON (B)(6) 2025 07:26:20, (B)(6) CENTER, T1430-01 TELE WEAK SIGNAL GENERATED AT 07:26:13. PIC IX: TH14ESV1, LOGGED INOP. ON (B)(6) 2025 07:25:49, (B)(6) CENTER, T1430-01 SECTOR: NO SPO2T, BATT LOW GENERATED AT 07:25:48. PIC IX: TH14ESV1, LOGGED INOP. ON (B)(6) 2025 07:25:49, (B)(6) CENTER, T1430-01 DESAT 27 < 85 ENDED. T14E-TEL13, RED ALARM. ON (B)(6) 2025 07:25:49. (B)(6) CENTER, T1430-01 SECTOR: DESAT 27 < 85 ENDED. PIC IX: TH14ESV1, RED ALARM. ON (B)(6) 2025 07:25:49, (B)(6) CENTER, T1430-01 NO SPO2T, BATT LOW GENERATED AT 07:25:48. T14E-TEL13, LOGGED INOP. ON (B)(6) 2025 07:25:16, INOP SOUND PLAYED. PIC IX: TH14ESV2, ALERT SOUND. ON (B)(6) 2025 07:25:10, YELLOW ALARM SOUND PLAYED. PIC IX: TH14ESV2, ALERT SOUND. ON (B)(6) 2025 07:23:45, INOP SOUND PLAYED. PIC IX: TH14ESV1, ALERT SOUND. ON (B)(6) 2025 07:23:45, (B)(6) CENTER, T1430-01 ACKNOWLEDGE, PIC IX: TH14ESV1 ACKNOWLEDGE. ON (B)(6) 2025 07:23:44, (B)(6) CENTER, T1430-01 ACKNOWLEDGE, PIC IX: TH14ESV1 ACKNOWLEDGE. ON (B)(6) 2025 07:23:44, (B)(6) CENTER, T1430-01 ACKNOWLEDGE, PIC IX: TH14ESV1 ACKNOWLEDGE. ON (B)(6) 2025 07:23:38, RED ALARM SOUND PLAYED. PIC IX: TH14ESV1, ALERT SOUND. ON (B)(6) 2025 07:23:38, (B)(6) CENTER, T1430-01 SECTOR: DESAT 81 < 85 GENERATED AT 07:23:34. PIC IX: TH14ESV1, RED ALARM. ON (B)(6) 2025 07:23:38, (B)(6) CENTER, T1430-01 SPO2T, 81 <88 ENDED. T14E-TEL13 YELLOW ALARM. ON (B)(6) 2025 07:23:38, (B)(6) CENTER, T1430-01 SECTOR: SPO2T, 81 <88 ENDED. PIC IX: TH14ESV1 YELLOW ALARM. ON (B)(6) 2025 07:23:38, (B)(6) CENTER, T1430-01 DESAT, 81 < 85 GENERATED AT 07:23:34. T14E-TEL13 RED ALARM. ON (B)(6) 2025 07:23:14, INOP SOUND PLAYED. PIC IX: TH14ESV2, ALERT SOUND. ON (B)(6) 2025 07:14:23, (B)(6) CENTER, T1430-01 SECTOR: TELE BATTERY LOW GENERATED AT 07:14:21. PIC IX: TH14ESV1 LOGGED INOP. ON (B)(6) 2025 07:14:23, (B)(6) CENTER, T1430-01 TELE BATTERY LOW GENERATED AT 07:14:21. T14E-TEL13 LOGGED INOP. ON (B)(6) 2025 07:14:21, (B)(6) CENTER, T1430-01 USER REQUEST: ECG - ECG OFF, T14E-TEL13 MEASUREMENT ON/OFF. BASED ON THE INFORMATION AVAILABLE, THE CUSTOMER'S ALLEGED MALFUNCTION COULD NOT BE CONFIRMED. THE REPORTED PROBLEM WAS NOT CONFIRMED. 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 THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS A SUPPLEMENTAL TO (1218950-2025-000706) DUE TO INCORRECT REGISTRATION NUMBER USED. BOX D: BASED UPON UPDATED INFORMATION, PRODUCT NAME CHANGED FROM 865351 MX40 2.4 GHZ SMART HOPPING (B)(4) TO 866389 PATIENT INFORMATION CENTER IX (B)(4) A PHILIPS KEY ACCOUNT MANAGER RECALLS WHILE PERFORMING DEVICE INVENTORY FOR THE HOSPITAL ON (B)(6) 2025 ON TISCH 14 WEST, WHEN A NURSE REPORTED A FEW MINUTES BEFORE HIS ONSITE ARRIVAL A PATIENT EXPIRED AT (7:15AM) WHILE BEING MONITORED ON THE UNIT. THE NURSE RECALLED THE PATIENT DESATURATED TO 30 BUT NO ALARM WAS ANNUNCIATED. THE PATIENT WAS IN TISCH 14-30, ON BED 1. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE MONITOR DID NOT GENERATE AN ALARM FOR AN OXYGEN DESATURATION OF 30% AND THE PATIENT PASSED AWAY. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44327 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH PATIENT INFORMATION CENTER IX 4.0.1.0 00884838104594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D