BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 15086090 · Received July 22, 2022

    Report

    Report Number
    1218950-2022-00629
    Event Type
    Death
    Date Received
    July 22, 2022
    Date of Event
    June 23, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    EVALUATION: THE LOGS WERE OBTAINED AND WERE REVIEWED BY A PHILIPS CLINICAL PRODUCT SPECIALIST (CPS). THE CPS NOTED THAT THE CUSTOMER REPORTED THAT THE MONITOR GENERATED AN ALARM AT 1400 AND WAS SILENCED AT THE MONITOR. THERE WAS A VENT FIB/TACH ALARM GENERATED AT 1400 AND THERE WAS NOT ANY SILENCING OF THIS ALARM AT THE MONITOR OR AT THE PIC IX. ACCORDING TO THE CONFIGURATION FILE, RED ALARMS ARE LATCHED VISUALLY AND AUDIBLE. WITH THIS CONFIGURATION, THE USER WOULD HAVE CONTINUED TO HEAR THE RED ALARM SOUNDED AT THE PIC IX AND THE BEDSIDE. FROM 16:09 ON, THERE WERE MANY ECG LEADS OFF GENERATED AND ENDED. AT 16:40 AN ECG LEADS OFF WAS GENERATED AND REMAINED. AT 17:50, THE ALARMS (VENT FIB/TACH AND ECG LEADS OFF) WERE SILENCED FROM THE MONITOR. THE SILENCE ACTION ENDED THE VENT FIB/TACH ALARM, BUT THE ECG LEAD OFF CONTINUED. THE ACTION NOTED FOR THIS BED BY THE CPS WAS AT 18:19 WHEN SILENCE OCCURRED AT THE PIC IX. THE PRODUCT DID NOT FAIL TO MEET SPECIFICATIONS. AUDIT LOG (B)(6) 2022 12:49 ED6 ASYSTOLE GENERATED AT 12:49:00. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 12:49 ED6 RR 35 >30 GENERATED AT 12:49:19. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 12:49 ED6 RR 35 >30 ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 202212:50 ED6 RR 41 >30 GENERATED AT 12:49:50. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 12:50 ED6 RR 41 >30 ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 12:58 ED6 RR 38 >30 GENERATED AT 12:57:58. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 12:58 ED6 RR 38 >30 ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 13:05 ED6 RR 43 >30 GENERATED AT 13:05:03. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 13:05 ED6 RR 43 >30 ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 13:07 ED6 RR 46 >30 GENERATED AT 13:06:57. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 13:07 ED6 RR 46 >30 ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 13:10 ED6 SILENCE ERMON6; (B)(6) 2022 13:10 ED6 ASYSTOLE ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 13:41 ED6 PVCS/MIN 17 >15 GENERATED AT 13:41:26. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 13:44 ED6 PVCS/MIN 19 >15 ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 14:00 ED6 VENT FIB/TACH GENERATED AT 14:00:36. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:09 ED6 ECG LEADS OFF GENERATED AT 16:09:01. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:09 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:09 ED6 ECG LEADS OFF GENERATED AT 16:09:09. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:09 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:09 ED6 ECG LEADS OFF GENERATED AT 16:09:37. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:10 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:10 ED6 ECG LEADS OFF GENERATED AT 16:09:45. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:10 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:10 ED6 ECG LEADS OFF GENERATED AT 16:09:54. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:10 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:10 ED6 ECG LEADS OFF GENERATED AT 16:09:57. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:10 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:11 ED6 ECG LEADS OFF GENERATED AT 16:10:45. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:11 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:11 ED6 ECG LEADS OFF GENERATED AT 16:11:18. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:11 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:16 ED6 ECG LEADS OFF GENERATED AT 16:16:14. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:16 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:16 ED6 ECG LEADS OFF GENERATED AT 16:16:23. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:16 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:16 ED6 ECG LEADS OFF GENERATED AT 16:16:28. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:16 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:16 ED6 ECG LEADS OFF GENERATED AT 16:16:37. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:16 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:17 ED6 ECG LEADS OFF GENERATED AT 16:16:47. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:17 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:17 ED6 ECG LEADS OFF GENERATED AT 16:16:50. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:17 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:17 ED6 ECG LEADS OFF GENERATED AT 16:17:02. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:17 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:17 ED6 ECG LEADS OFF GENERATED AT 16:17:19. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:17 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:17 ED6 ECG LEADS OFF GENERATED AT 16:17:27. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:18 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:18 ED6 ECG LEADS OFF GENERATED AT 16:18:01. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 16:18 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01; 6/23/2022 16:40 ED6 ECG LEADS OFF GENERATED AT 16:40:18. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 17:50 ED6 SILENCE ERMON6; (B)(6) 2022 17:50 ED6 VENT FIB/TACH ENDED. PIIC IX: BMPHGIXS-ED01; (B)(6) 2022 18:19 ED6 SILENCE BMPHGIXS-ED01; RESOLUTION AND CONCLUSION: THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ISSUE. FROM THE REVIEW OF THE AUDIT LOG, THE PIC IX PERFORMED AS EXPECTED BASED ON THE ACTIONS CAPTURED IN THE AUDIT LOG AND THE CONFIGURATION FILE THAT WAS PROVIDED. THE MONITOR IS CONFIGURED FOR VISUAL AND AUDIBLE LATCHING SET TO RED ALARMS ONLY. THE CPS NOTED THAT A VENT FIB/TACH ALARM WAS GENERATED AT 14:00 AND ENDED AT 17:50 WHEN THE MONITOR WAS SILENCED. INFORMATION WAS PROVIDED TO THE CUSTOMER TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WANTED TO PULL LOGS TO REVIEW ALARM INFORMATION AND RESPONSIVENESS DUE TO A PATIENT DEATH ON (B)(6) 2022 BETWEEN 14:00 - 18:00 ON BED ED6/ERMON6. THE CUSTOMER WISHED TO KNOW IF THE PATIENT INFORMATION CENTER IX (PIC IX) CENTRAL STATION ALARMED AS IT SHOULD DURING TIME OF INCIDENT.

    Description of Event or Problem · 0

    PROBLEM STATEMENT: IT WAS REPORTED THAT THE CUSTOMER WANTED TO PULL LOGS TO REVIEW ALARM INFORMATION AND RESPONSIVENESS DUE TO A PATIENT DEATH ON (B)(6) 2022 BETWEEN 14:00 - 18:00 ON BED ED6/ERMON6. THE CUSTOMER WISHED TO KNOW IF THE PATIENT INFORMATION CENTER IX (PIC IX) CENTRAL STATION ALARMED AS IT SHOULD DURING TIME OF INCIDENT. THE DEVICE WAS IN USE. A PATIENT DEATH WAS REPORTED, HOWEVER THE INVESTIGATION FOUND THAT THE DEVICE ALARMED AS INTENDED. EVALUATION: THE LOGS WERE OBTAINED AND WERE REVIEWED BY A PHILIPS CLINICAL PRODUCT SPECIALIST (CPS). THE CPS NOTED THAT THE CUSTOMER REPORTED THAT THE MONITOR GENERATED AN ALARM AT 1400 AND WAS SILENCED AT THE MONITOR. THERE WAS A VENT FIB/TACH ALARM GENERATED AT 1400 AND THERE WAS NOT ANY SILENCING OF THIS ALARM AT THE MONITOR OR AT THE PIC IX. ACCORDING TO THE CONFIGURATION FILE, RED ALARMS ARE LATCHED VISUALLY AND AUDIBLE. WITH THIS CONFIGURATION, THE USER WOULD HAVE CONTINUED TO HEAR THE RED ALARM SOUNDED AT THE PIC IX AND THE BEDSIDE. FROM 16:09 ON, THERE WERE MANY ECG LEADS OFF GENERATED AND ENDED. AT 16:40 AN ECG LEADS OFF WAS GENERATED AND REMAINED. AT 17:50, THE ALARMS (VENT FIB/TACH AND ECG LEADS OFF) WERE SILENCED FROM THE MONITOR. THE SILENCE ACTION ENDED THE VENT FIB/TACH ALARM, BUT THE ECG LEAD OFF CONTINUED. THE ACTION NOTED FOR THIS BED BY THE CPS WAS AT 18:19 WHEN SILENCE OCCURRED AT THE PIC IX. THE PRODUCT DID NOT FAIL TO MEET SPECIFICATIONS. AUDIT LOG (B)(6) 2022 12:49 ED6 ASYSTOLE GENERATED AT 12:49:00. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 12:49 ED6 **RR 35 >30 GENERATED AT 12:49:19. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 12:49 ED6 **RR 35 >30 ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 12:50 ED6 **RR 41 >30 GENERATED AT 12:49:50. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 12:50 ED6 **RR 41 >30 ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 12:58 ED6 **RR 38 >30 GENERATED AT 12:57:58. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 12:58 ED6 **RR 38 >30 ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 202213:05 ED6 **RR 43 >30 GENERATED AT 13:05:03. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 13:05 ED6 **RR 43 >30 ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 202213:07 ED6 **RR 46 >30 GENERATED AT 13:06:57. PIIC IX: BMPHGIXS-ED01 (B)(6) 202213:07 ED6 **RR 46 >30 ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 13:10 ED6 SILENCE ERMON6 (B)(6) 2022 13:10 ED6 *** ASYSTOLE ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 13:41 ED6 * PVCS/MIN 17 >15 GENERATED AT 13:41:26. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 13:44 ED6 * PVCS/MIN 19 >15 ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 14:00 ED6 *** VENT FIB/TACH GENERATED AT 14:00:36. PIIC IX: BMPHGIXS-ED01 (B)(6) 202216:09 ED6 ECG LEADS OFF GENERATED AT 16:09:01. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:09 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:09 ED6 ECG LEADS OFF GENERATED AT 16:09:09. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:09 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:09 ED6 ECG LEADS OFF GENERATED AT 16:09:37. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:10 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:10 ED6 ECG LEADS OFF GENERATED AT 16:09:45. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:10 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:10 ED6 ECG LEADS OFF GENERATED AT 16:09:54. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:10 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:10 ED6 ECG LEADS OFF GENERATED AT 16:09:57. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:10 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:11 ED6 ECG LEADS OFF GENERATED AT 16:10:45. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:11 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:11 ED6 ECG LEADS OFF GENERATED AT 16:11:18. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:11 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:16 ED6 ECG LEADS OFF GENERATED AT 16:16:14. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:16 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:16 ED6 ECG LEADS OFF GENERATED AT 16:16:23. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:16 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:16 ED6 ECG LEADS OFF GENERATED AT 16:16:28. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:16 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:16 ED6 ECG LEADS OFF GENERATED AT 16:16:37. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:16 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 202216:17 ED6 ECG LEADS OFF GENERATED AT 16:16:47. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:17 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:17 ED6 ECG LEADS OFF GENERATED AT 16:16:50. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:17 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:17 ED6 ECG LEADS OFF GENERATED AT 16:17:02. PIIC IX: BMPHGIXS-ED01 (B)(6) 202216:17 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:17 ED6 ECG LEADS OFF GENERATED AT 16:17:19. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:17 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:17 ED6 ECG LEADS OFF GENERATED AT 16:17:27. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:18 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:18 ED6 ECG LEADS OFF GENERATED AT 16:18:01. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:18 ED6 ECG LEADS OFF ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 16:40 ED6 ECG LEADS OFF GENERATED AT 16:40:18. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 17:50 ED6 SILENCE ERMON6 (B)(6) 2022 17:50 ED6 *** VENT FIB/TACH ENDED. PIIC IX: BMPHGIXS-ED01 (B)(6) 2022 18:19 ED6 SILENCE BMPHGIXS-ED01 RESOLUTION AND CONCLUSION: THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ISSUE. FROM THE REVIEW OF THE AUDIT LOG, THE PIC IX PERFORMED AS EXPECTED BASED ON THE ACTIONS CAPTURED IN THE AUDIT LOG AND THE CONFIGURATION FILE THAT WAS PROVIDED. THE MONITOR IS CONFIGURED FOR VISUAL AND AUDIBLE LATCHING SET TO RED ALARMS ONLY. THE CPS NOTED THAT A VENT FIB/TACH ALARM WAS GENERATED AT 14:00 AND ENDED AT 17:50 WHEN THE MONITOR WAS SILENCED. INFORMATION WAS PROVIDED TO THE CUSTOMER TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607902 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death