BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 14111774 · Received April 14, 2022

    Report

    Report Number
    1218950-2022-00336
    Event Type
    Death
    Date Received
    April 14, 2022
    Date of Event
    March 22, 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
    MI, 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

    A PHILIPS TECHNICAL CONSULTANT WENT ONSITE TO PULL THE AUDIT LOGS FROM THE REPORTED EVENT. THE AUDIT LOGS WERE REVIEWED BY THE TC AND A PHILIPS CLINICAL PRODUCT SPECIALISTS (CPS) AND THEY SHOW THAT THE CENTRAL STATION WAS ALARMING AS INTENDED. THE AUDIT LOGS SHOW THE FOLLOWING INFORMATION; (B)(6) 2022 21:00 H514B * PACER NOT PACING GENERATED AT 21:00:31. (HR = 84) PIIC IX: H5SURV01 (B)(6) 2022 21:03 H514B * PACER NOT PACING ENDED. PIIC IX: H5SURV01 (B)(6) 2022 21:19 H514B * PVCS/MIN 11 >10 GENERATED AT 21:19:49. (PVC = 11) PIIC IX: H5SURV01 (B)(6) 2022 21:22 H514B *** VENT FIB/TACH GENERATED AT 21:22:09. (HR = 94) PIIC IX: H5SURV01 (B)(6) 2022 21:22 H514B * PVCS/MIN 11 >10 ENDED. PIIC IX: H5SURV01 (B)(6) 2022 21:36 H514B *** ASYSTOLE GENERATED AT 21:36:40. (HR = 0) PIIC IX: H5SURV01 (B)(6) 2022 21:36 H514B *** VENT FIB/TACH ENDED. PIIC IX: H5SURV01 (B)(6) 2022 23:54 H514B ECG LEADS OFF GENERATED AT 23:54:50. PIIC IX: H5SURV01 (B)(6) 2022 23:55 H514B !!!ECG LEADS OFF GENERATED AT 23:54:53. PIIC IX: H5SURV01 (B)(6) 2022 23:55 H514B ECG LEADS OFF ENDED. PIIC IX: H5SURV01 (B)(6) 2022 0:20 H514B !!!ECG LEADS OFF ENDED. PIIC IX: H5SURV01 (B)(6) 2022 0:20 H514B *** ASYSTOLE ENDED. PIIC IX: H5SURV01 (B)(6) 2022 0:20 H514B EQUIPMENT IN STANDBY T_H514B (B)(6) 2022 0:20 H514B ARRHYTHMIA OFF T_H514B (B)(6) 2022 0:20 H514B EQUIPMENT OFFLINE T_H514B THE CUSTOMER ALSO ALLEGED THAT THE ALARMS WERE NOT PAGED OUT TO THEIR ASCOM PHONES. THE EMERGIN LOGS WERE PULLED AND IT CAN BE SEEN THAT ALL CRITICAL ALARMS WERE SENT TO MULTIPLE NURSES PHONES AND THAT TWO OF THE SIX RECIPIENTS OF THE PAGED ALARMS READ THE MESSAGE NINE TO ELEVEN MINUTES AFTER IT OCCURRED. THERE WAS NO MALFUNCTION OF THE PHILIPS SYSTEM. THE AUDIT LOGS WERE PULLED WHICH PROVED THAT THE CUSTOMERS PATIENT INFORMATION CENTER IX AND THE PAGING SYSTEM ALARMED AS INTENDED. THE DEVICE REMAINS ON SITE AND IN USE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR CENTRAL STATION AND PAGING SYSTEM FAILED TO ALARM FOR A PATIENT THAT DIED ON (B)(6) 2022.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR CENTRAL STATION AND PAGING SYSTEM FAILED TO ALARM FOR A PATIENT THAT DIED ON (B)(6) 2022 BETWEEN 9:30 AND 12:00 AM (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146769 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death