BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 9582700 · Received January 13, 2020

    Report

    Report Number
    1218950-2020-00272
    Event Type
    Death
    Date Received
    January 13, 2020
    Date of Event
    December 20, 2019
    Report Date
    January 6, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838086715
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A PHILIPS RESPONSE CENTER ENGINEER (RCE) SPOKE TO THE CUSTOMER, AND WAS TOLD THAT THERE WAS AN ALARM FAILURE. THE CUSTOMER WOULD NOT SAY WHICH TYPE OF ALARM FAILED. THE CUSTOMER INDICATED THAT THE ISSUE OCCURRED ON BED 2 BETWEEN (B)(6) 2019 21:37 TO (B)(6) 2019 00:42. THE RCE REVIEWED THE LOG DATA FOR THE TIME REPORTED, AND FOUND MULTIPLE INSTANCES OF ECG LEAD TECHNICAL ALARMS BEING GENERATED. AT 21:38:52 A RED DESAT WAS GENERATED, WHICH WAS ACKNOWLEDGED AT THE BEDSIDE MONITOR AT 23:38:55. IT WAS SEEN THAT THE ALARM WAS PAUSED. THE RCE THEN FOUND THAT SPO2 / PULSE MONITORING WAS SWITCHED OFF AT 21:43:01 AT THE BEDSIDE MONITOR. THE RCE NOTED THAT DURING THE WHOLE MONITORING PERIOD, THERE WERE TECHNICAL ALARMS REGARDING THE ECG ANALYSIS / PULSE MONITORING. THE ALARMS WERE REACTED TO BY ACKNOWLEDGING THEM AT THE BEDSIDE MONITOR. HOWEVER, THE TECHNICAL PROBLEMS WERE NOT SOLVED WITH THE ECG; THEREFORE, AFTER SWITCHING OFF THE SPO2 MONITORING THERE WAS NO LONGER A FUNCTIONING MEASUREMENT FOR PATIENT MONITORING. AT 00:42 THE PATIENT WAS DISCHARGED. THERE WAS NO PRODUCT MALFUNCTION; THIS IS CONSIDERED A USER ISSUE, AS ALARMS DID OCCUR, AND HAD BEEN SWITCHED OFF, AND REOCCURRING ECG/PULSE TECHNICAL ALARMS WERE NOT RESOLVED. THIS INFORMATION WAS PROVIDED TO THE CUSTOMER. THE DEVICE REMAINS IN USE AT THE CUSTOMER SITE. NO SUBSEQUENT CALLS HAVE BEEN LOGGED FOR THIS DEVICE/ISSUE. NO FURTHER INVESTIGATION OR ACTION IS WARRANTED AT THIS TIME. .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS AN INCIDENT AT THE HOSPITAL RESULTING IN DEATH. THE TYPE OF INCIDENT WAS NOT PROVIDED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43198 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389 00884838086715

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death