BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAREEVENT REL A.0

    MDR report key: 7464322 · Received April 26, 2018

    Report

    Report Number
    1218950-2018-03696
    Event Type
    Death
    Date Received
    April 26, 2018
    Date of Event
    April 19, 2018
    Report Date
    April 20, 2018
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MSX
    UDI-DI
    00884838081284
    PMA / PMN Number
    K142935
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. PATIENT INFORMATION HAS BEEN REQUESTED. DATE OF DEATH HAS BEEN REQUESTED AND NOT AVAILABLE AT TIME OF REPORT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD QUESTIONS REGARDING PHONE ALERTS FOR AN ASYSTOLE ALARM THAT OCCURRED WITH THE PATIENT. IT WAS QUESTIONED WHETHER THE MOBILE PHONE (CAREEVENT) ALERT WAS AT THE SAME TIME OF THE PIIC IX ALERT. THE CUSTOMER STATED THAT THE CUSTOMER HAD LOOKED AT THE PIIC IX CLINICAL AUDIT LOGS AND WAS SEEING AN ASYSTOLE ALARM AT 06:56:01 WHEREAS THE CAREEVENT PHONE ALERT SHOWS BEING AT 07:40. THE PIIC IX CLINICAL AUDIT LOGS GATHERED FROM THE PIIC IX CENTRAL STATION SHOW THAT THE ASYSTOLE ALARM FROM 6:56:01 (BEDSIDE ALARM) WAS RECEIVED AT THE PIIC AND TIME STAMPED AT 06:55AM. THIS TIME DIFFERENCE IS ATTRIBUTED TO THE TIME STAMP DIFFERENCE BETWEEN THE VARIOUS SYSTEMS AND DOES NOT MEAN THAT THERE WAS ANY LAPSE IN TIME. PHILIPS RECOMMENDS SYNCHRONIZING THE TIME SERVERS TO PROVIDE BETTER UNDERSTANDING OF THE ALARMS BETWEEN SYSTEMS. THIS ALARM WAS THEN SENT FROM THE PIIC IX TO THE CAREEVENT MOBILE ALERT SYSTEM. THE CAREEVENT EVENT TRANSCRIPT GATHERED FROM THE CAREEVENT SERVER SHOWS THAT ON (B)(6) 2018 FOR 663-2 THAT THERE WAS A THREE STAR RED. ASYSTOLE ALARM AT 6:56:01 AM (ANNOUNCE TIME RECEIVED AT THE PIIC IX) WHICH WAS SUCCESSFULLY MATCHED TO THE CAREEVENT SYSTEM'S LOCATION INFORMATION. THE ASYSTOLE FROM 06:56:01 WAS SENT TO CAREEVENT AND CAREEVENT WAS NOTIFIED AT 06:53:15 (CAREEVENT TIME STAMP). A REVIEW OF THE CAREEVENT ALARM EVENT TRANSCRIPTS SHOWS THAT THE PHONE ALERTS WERE BEING PROVIDED PER NORMAL OPERATION. THE CAREEVENT TRANSCRIPTS SHOW THAT THE ASYSTOLE ALERT WAS DELIVERED TO THE 1ST LEVEL PHONE AND ESCALATED TO THE 2ND LEVEL PHONE AFTER 30 SECONDS WITHOUT ACKNOWLEDGEMENT, WHERE THE 2ND LEVEL ALERT WAS DELIVERED TO THE 2ND LEVEL CAREGIVER ONE SECOND LATER. THE ASYSTOLE IS SHOWN AS BEING "READ" AT 7:17AM. REMINDERS WERE ALSO PROVIDED TO THE 1ST AND 2ND LEVEL CAREGIVERS EVERY THREE MINUTES UNTIL 7:59. THERE IS NO DATA TO SUPPORT A MALFUNCTION OF THE CAREEVENT SYSTEM. INFORMATION WAS SUPPLIED TO THE CUSTOMER VIA WRITTEN RESPONSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOSPITAL STAFF AT THE SITE WAS PERFORMING AN INVESTIGATION OF A PATIENT EVENT WHERE THE PATIENT EXPIRED BETWEEN 6:40AM -7:40AM. THE CUSTOMER WANTED TO UNDERSTAND IF THERE WAS A DELAY IN CARE EVENT SENDING ALERTS TO THE MOBIL PHONES. INVESTIGATION IS NEEDED TO UNDERSTAND IF ANY PHILIPS PRODUCT CAUSED OR CONTRIBUTED TO THE PATIENT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309686 CAREEVENT REL A.0 CARDIAC MONITOR MSX PHILIPS MEDICAL SYSTEMS 866435 00884838081284

    Patients

    Seq Age Sex Outcome Treatment
    1 Death