BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 6055589 · Received October 25, 2016

    Report

    Report Number
    1218950-2016-06563
    Event Type
    Death
    Date Received
    October 25, 2016
    Date of Event
    September 25, 2016
    Report Date
    September 27, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE SITE RISK MANAGEMENT INVESTIGATOR (BSN, RN) WAS CONTACTED AND SHE STATED THAT THERE WAS NO ALLEGATION THAT ANY PHILIPS DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT EVENT. SHE SAID THAT STAFF WAS WELL AWARE OF THE NETWORK SERVICING THAT WAS BEING PERFORMED AND THAT THEY WERE AWARE THAT THE PATIENT COULD NOT BE CONNECTED TO TELEMETRY. THE PATIENT WAS PLACED ON A PORTABLE MONITOR AND WAS BEING MONITORED WITHOUT PROBLEMS OR ISSUES IN THE PATIENT ROOM. SHE STATED THAT THERE WAS A CAREGIVER IN THE ROOM WHEN THE PATIENT HAD THE ADVERSE EVENT. THERE IS NO DATA TO SUPPORT A PHILIPS DEVICE MALFUNCTION OR THAT A PHILIPS DEVICE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SENTINEL EVENT WHERE THE PATIENT WAS TO BE PUT ON A TELEMETRY DEVICE FOR MONITORING PER DOCTOR'S ORDERS. THE TELEMETRY MONITORING SYSTEM WAS DOWN AT THAT TIME. WHILE THE TELEMETRY WAS DOWN THE PATIENT IN THE ER WAS TRANSFERRED TO A MONITORED BED. THE CUSTOMER STATED THAT THE PATIENT EXPIRED DURING THE TIME THAT THE TELEMETRY MONITORING SYSTEM WAS DOWN AND THEREFORE THE PATIENT COULD NOT BE PLACED ON A TELEMETRY DEVICE FOR MONITORING AND THUS PHILIPS MAY BE SEEN AS BEING AT FAULT FOR THE ADVERSE PATIENT EVENT. IT HAS NOT BEEN ESTABLISHED AS YET WHETHER THE PATIENT HAD ANY TYPE OF MONITORING BEING PERFORMED BEFORE THE ADVERSE EVENT OR DURING THE ADVERSE EVENT. THAT INFORMATION WAS REQUESTED BUT HAS NOT BEEN SUPPLIED BY RISK MANAGEMENT TO THIS POINT. THE ISSUE IS CONSIDERED AS REPORTABLE AWAITING FURTHER INFORMATION CONCERNING THE CIRCUMSTANCES SURROUNDING THE ADVERSE EVENT AND HOW THE TELEMETRY MONITORING SYSTEM BEING DOWN COULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE PATIENT EVENT. THE PATIENT WAS IN THE ER AND WAS TO BE TRANSFERRED TO A MONITORED BED SINCE THE PATIENT WAS TO BE PLACED ON TELEMETRY PER THE DOCTOR'S ORDER AND THE TELEMETRY MONITORING SYSTEM BEING DOWN. THE PATIENT CODED AND DIED DURING THE TELEMETRY MONITORING DOWN TIME. IT IS NOT KNOWN WHETHER THE PATIENT HAD ANY TYPE OF MONITORING BEING PERFORMED BEFORE THE ADVERSE EVENT OR DURING THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705388 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389

    Patients

    Seq Age Sex Outcome Treatment
    1 Death