BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 19340491 · Received May 17, 2024

    Report

    Report Number
    1218950-2024-00363
    Event Type
    Death
    Date Received
    May 17, 2024
    Date of Event
    April 24, 2024
    Report Date
    June 5, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838048645
    PMA / PMN Number
    K153702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE WITH THE CUSTOMER AND CUSTOMER WAS ALLEGING THAT THE PATIENT PASSED AWAY AND THEY REQUESTED THE CLINICAL LOGS FROM BED 9 BETWEEN 11AM ON (B)(6) 2024 TO 4AM (B)(6) 2024 IN DETERMINING IF ALARMS WERE SILENCED AND, IF SO, WERE THEY SILENCED AT THE BEDSIDE OR CENTRAL. A PHILIPS PRODUCT SPECIALIST ENGINEER (PSE) AND A CLINICAL APPLICATION SPECIALIST (CAS) REVIEWED THE AUDIT LOGS PROVIDED BY THE CUSTOMER. THE RESULTS OF AUDIT LOG ANALYSIS ARE AS FOLLOWING: THERE WERE MANY ALARM SOUNDS BEING PLAYED OVERALL ON THE SURVEILLANCE PM_L19HW. HOWEVER, IN BED 9 FROM 10PM ON (B)(6) 2024 TO 4AM ON (B)(6) 2024, THEN AROUND 10:13PM TO 10:51PM, THERE WERE RED ALARMS FOR THE BRADY ALARM THAT WERE SILENCED ON THE BEDSIDE. THERE WERE OTHER ALARMS THAT OCCURRED ON BED 9 ALL THE WAY TO 3AM ON (B)(6) 2024, BUT THERE WERE NO RED ALARM OR YELLOW ALARMS. ON (B)(6) 2024 22:24 BED 9 * MULTIFORM PVCS ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 22:13 BED 9 ***XBRADY 37 <38 GENERATED AT 22:13:27. PIIC IX: PM_L19HW ON (B)(6) 2024 22:13 BED 9 * MISSED BEAT ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 22:14 BED 9 ***XBRADY 37 <38 ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 22:21 BED 9 * MULTIFORM PVCS GENERATED AT 22:21:17. PIIC IX: PM_L19HW ON (B)(6) 2024 22:24 BED 9 MULTIFORM PVCS ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 22:27 BED 9 XBRADY 37 <38 GENERATED AT 22:26:57. PIIC IX: PM_L19HW ON (B)(6) 2024 22:27 BED 9 SILENCE PM_L19HW ON (B)(6) 2024 22:27 BED 9 SILENCE PM_L19HW ON (B)(6) 2024 22:27 BED 9 SILENCE PM_L19HW ON (B)(6) 2024 22:27 BED 9 XBRADY 37 <38 ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 22:32 BED 9 MULTIFORM PVCS GENERATED AT 22:31:53. PIIC IX: PM_L19HW ON (B)(6) 2024 22:35 BED 9 MULTIFORM PVCS ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 22:42 BED 9 MULTIFORM PVCS GENERATED AT 22:42:22. PIIC IX: PM_L19HW ON (B)(6) 2024 22:45 BED 9 MULTIFORM PVCS ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 22:50 BED 9 PAIR PVCS GENERATED AT 22:49:36. PIIC IX: PM_L19HW ON (B)(6) 2024 22:51 BED 9 XBRADY 37 <38 GENERATED AT 22:50:47. PIIC IX: PM_L19HW ON (B)(6) 2024 22:51 BED 9 PAIR PVCS ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 22:51 BED 9 SILENCE PM_L19HW ON (B)(6) 2024 22:51 BED 9 XBRADY 37 <38 ENDED. PIIC IX: PM_L19HW THERE WERE ALSO ECG LEADS OFF GENERATED ON AND OFF AS WELL WHICH COULD MEAN THAT THE LEADS WERE NOT HOOKED TO THE PATIENT PROPERLY WHICH COULD AFFECT THE READINGS AND ALARMS FOR THAT PATIENT ON BED 9. ON (B)(6) 2024 0:56 BED 9 ECG LEADS OFF GENERATED AT 00:56:23. PIIC IX: PM_L19HW ON (B)(6) 2024 0:57 BED 9 * IRREGULAR HR ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 1:13 BED 9 ECG LEADS OFF ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 1:14 BED 9 ECG LEADS OFF GENERATED AT 01:14:05. PIIC IX: PM_L19HW ON (B)(6) 2024 1:25 BED 9 ECG LEADS OFF ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 1:27 BED 9 ECG LEADS OFF GENERATED AT 01:27:06. PIIC IX: PM_L19HW ON (B)(6) 2024 1:27 BED 9 ECG LEADS OFF ENDED. PIIC IX: PM_L19HW ON (B)(6) 2024 1:30 BED 9 SILENCE PM_L19HW ON (B)(6) 2024 2:52 BED 9 ECG LEADS OFF GENERATED AT 02:52:11. PIIC IX: PM_L19HW ON (B)(6) 2024 2:58 BED 9 SILENCE PM_L19HW A GOOD FAITH EFFORT (GFE) WAS PERFORMED TO OBTAIN THE ADDITIONAL INFORMATION ABOUT THE PATIENT¿S DEATH. THE INFORMATION PROVIDED INDICATED THAT THERE WAS NO ALLEGED MALFUNCTION, NOR WAS THERE AN ALLEGATION THE DEVICE WAS RELATED TO THE PATIENT'S DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES SURROUNDING THE DEATH. BASED ON THE INFORMATION, THERE WAS NO MALFUNCTION BECAUSE THE DEVICE WAS WORKING AS INTENDED AND THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED DEATH. 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

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. REPORTING ADDRESS STATE: (B)(6). REPORTING INSTITUTION PHONE #: (B)(6). REPORTER PHONE #: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT PASSED AWAY AND THE CUSTOMER REQUESTED ASSISTANCE IN DETERMINING IF ALARMS WERE SILENCED AND, IF SO, WERE THEY SILENCED AT THE BEDSIDE OR CENTRAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2500354 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS MEDICAL SYSTEMS 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death