BEUDAMED
    FDA Adverse Event Death Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 12961143 · Received December 8, 2021

    Report

    Report Number
    1218950-2021-11166
    Event Type
    Death
    Date Received
    December 8, 2021
    Date of Event
    November 10, 2021
    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
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS REMOTE APPLICATIONS SPECIALIST (RAS) SPOKE WITH THE BIOMED WHO REQUESTED A ROOT CAUSE ANALYSIS FOR THE GAPS IN DATA. THE GAPS WERE IN THE WAVE REVIEW FOR BED 4B08 FROM APPROXIMATELY 09:00PM UNTIL WHEN THE PATIENT EXPIRED. THE RAS REVIEWED THE WAVE REVIEW AND NOTED A NO DATA MONITOR INOP. THE BIOMED WAS UNABLE TO CONFIRM IF THE BEDSIDE MONITOR LOST COMMUNICATION TO THE PIC IX AT THE TIME OF THE GAPS, OR IF THE PATIENT WAS BEING MOVED OR OTHERWISE DISCONNECTED. THE RAS REMOTELY ACCESSED THE CUSTOMER SYSTEM AND NOTED ECG LEADS OFF INOPS. THE CAUSE OF THE LOST COMMUNICATION IS UNKNOWN. HOWEVER IF COMMUNICATION IS LOST, THE BEDSIDE WILL ISSUE A NO CENTRAL MONITORING INOP WHEN THE LOSS OF COMMUNICATION IS DETECTED. IN A SEPARATE REPORT OF THIS ISSUE, THE CUSTOMER INDICATED THAT THE PATIENT WAS BEING MONITORED AT ALL TIMES DURING THIS INCIDENT. A PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSIST THE BIOMED ONSITE. UPON ARRIVAL, THE FSE DETERMINED THAT THE SOFTWARE REQUIRED UPGRADE TO B.02.18 FOR THE DATABASE SERVER AND PHYSIO SERVER. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED CLINICAL APPLICATION SUPPORT. THE RAS PROVIDED INFORMATION TO THE CUSTOMER TO EXPLAIN THE POSSIBLE CAUSE OF THE DATA GAPS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT A PATIENT EXPIRED, AND WHILE A NURSE WAS TRYING TO REVIEW DATA ON THE PATIENT, THEY NOTED THERE WAS NO CONSISTENT DATA AVAILABLE AT THEIR PHILIPS INFORMATION CENTER IX (PIC IX). THE DEVICE WAS IN USE AT TIME OF EVENT, A PATIENT DIED.

    Description of Event or Problem · 0

    THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT A PATIENT EXPIRED, AND WHILE A NURSE WAS TRYING TO REVIEW DATA ON THE PATIENT, THEY NOTED THERE WAS NO CONSISTENT DATA AVAILABLE AT THEIR PHILIPS INFORMATION CENTER IX (PIC IX). THE DEVICE WAS IN USE AT TIME OF EVENT, A PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862172 PATIENT INFORMATION CENTER IX PATIENT INFORMATION CENTER IX MHX PHILIPS NORTH AMERICA LLC 866389 00884838048645

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death