BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS INFORMATION CENTER

    MDR report key: 5360210 · Received January 12, 2016

    Report

    Report Number
    1218950-2016-00107
    Event Type
    Death
    Date Received
    January 12, 2016
    Date of Event
    December 20, 2015
    Report Date
    December 20, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K011093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMEDICAL ENGINEER/IEM SYSTEM ADMINISTRATOR, THERE WAS NO ALLEGATION THAT ANY PHILIPS PRODUCT CAUSED OR CONTRIBUTED TO THE PATIENT EVENT. HE SAID THAT THERE WERE ALARMS AT THE CENTRAL THAT ALERTED THE STAFF THAT THE PATIENT WAS HAVING A CODE AND STAFF ADMINISTERED CARE TO THE PATIENT. AFTER THE PATIENT EXPIRED THE STAFF WANTED TO INVESTIGATE THE ISSUE AND WANTED TO DOCUMENT THE FINDINGS. PER IEM (INTELLIVUE EVENT MANAGEMENT) PRODUCT SUPPORT ENGINEER, IN RESPONSE TO THE SENTINEL EVENT THAT OCCURRED AT (B)(6) MEDICAL CENTER (B)(6) 2015 AM @ 8:24AM, PHILIPS CONDUCTED AN INVESTIGATION OF THE PHILIPS SOFTWARE AND CONCLUDED THAT THE SYSTEM FUNCTIONED AS DESIGNED. THE INVESTIGATION FOUND THAT 0 (B)(4) ALARM MESSAGES AND 3 PHILIPS TELEMETRY MESSAGES WERE DELIVERED FROM BED (B)(6) FROM 08:24:38 AM TO 08:32:18 AM. THE INPUT SYSTEM WAS PHILIPS AND (B)(4) SPECTRALINK NURSECALL. THE PHILIPS EVENT MANAGEMENT SYSTEM IS SOFTWARE VERSION 9.0. THE SITE HAS (B)(4) SPECTRALINK BUT NO SPECTRALINK PHONES WERE ASSIGNED. (B)(4) CHANGED THE CONFIGURATION OF THE TEXT OF THE ALERTS CAUSING PHILIPS ALARM MESSENGER WORKFLOW TO STOP FUNCTIONING AND NO ALERTS WERE SENT. THIS IS A 3RD PARTY (B)(4) SPECTRALINK CONFIGURATION ISSUE. THERE IS NO DATA TO SUPPORT A PHILIPS MALFUNCTION. IT IS CONSIDERED THAT AFTER THE 3RD PARTY SPECTRALINK NURSECALL SYSTEM WAS CONFIGURED CORRECTLY FOR THE SPECTRALINK PHONES THAT THE SYSTEM RESUMED NORMAL PAGING. NO FURTHER CALLS WERE LOGGED FOR THIS ISSUE AND THE PROBLEM WILL BE CONSIDERED AS RESOLVED. THE DEVICE REMAINS AT THE CUSTOMER SITE. NO MALFUNCTION. THE CUSTOMER REPORTED A PATIENT DEATH WHICH HAPPENED ON (B)(6) 2015 AM @ 8:24AM (B)(6). THE (B)(4) CODE BLUE ALERT NEEDED TO BE SENT TO ALL OAI (SPECTRALINK OPEN APPLICATION INTERFACE) PHONES, HOWEVER THE CUSTOMER STATED THAT NO PHONES RECEIVED THE ALERT. PER THE (B)(6) THERE WAS NO ALLEGATION THAT ANY PHILIPS PRODUCT CAUSED OR CONTRIBUTED TO THE PATIENT EVENT. HE SAID THAT THERE WERE ALARMS AT THE CENTRAL THAT ALERTED THE STAFF THAT THE PATIENT WAS HAVING A CODE AND STAFF ADMINISTERED CARE TO THE PATIENT. AFTER THE PATIENT EXPIRED THE STAFF WANTED TO INVESTIGATE THE ISSUE AND WANTED TO DOCUMENT THE FINDINGS. PER IEM (INTELLIVUE EVENT MANAGEMENT) PRODUCT (B)(6), IN RESPONSE TO THE SENTINEL EVENT THAT OCCURRED AT (B)(6) MEDICAL CENTER (B)(6) 2015 AM @ 8:24AM, PHILIPS CONDUCTED AN INVESTIGATION OF THE PHILIPS SOFTWARE AND CONCLUDED THAT THE SYSTEM FUNCTIONED AS DESIGNED. THE INVESTIGATION FOUND THAT 0 (B)(4) ALARM MESSAGES AND 3 PHILIPS TELEMETRY MESSAGES WERE DELIVERED FROM BED (B)(6) FROM 08:24:38 AM TO 08:32:18 AM. THE INPUT SYSTEM WAS PHILIPS AND (B)(4) SPECTRALINK NURSECALL. THE PHILIPS EVENT MANAGEMENT SYSTEM IS SOFTWARE VERSION 9.0. THE SITE HAS (B)(4) SPECTRALINK BUT NO SPECTRALINK PHONES WERE ASSIGNED. (B)(4) CHANGED THE CONFIGURATION OF THE TEXT OF THE ALERTS CAUSING PHILIPS ALARM MESSENGER WORKFLOW TO STOP FUNCTIONING AND NO ALERTS WERE SENT. THIS IS A 3RD PARTY (B)(4) SPECTRALINK CONFIGURATION ISSUE. THERE IS NO DATA TO SUPPORT A PHILIPS MALFUNCTION.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT DEATH WHICH HAPPENED ON (B)(6) 2015 AM AT 8:24AM ROOM 514. THE RAULAND CODE BLUE ALERT NEEDED TO BE SENT TO ALL OAI (SPECTRALINK OPEN APPLICATION INTERFACE) PHONES, HOWEVER THE CUSTOMER STATED THAT NO PHONES RECEIVED THE ALERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18370 PHILIPS INFORMATION CENTER CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS M3150B

    Patients

    Seq Age Sex Outcome Treatment
    1 Death