BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIC IX HARDWARE

    MDR report key: 16310458 · Received February 7, 2023

    Report

    Report Number
    1218950-2023-00073
    Event Type
    Death
    Date Received
    February 7, 2023
    Date of Event
    February 1, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K102495
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED. A PHILIPS FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND CONFIRMED THERE WAS NO MALFUNCTION ON THE PHILIPS PATIENT INFORMATION CENTER IX (PIC IX) AND IT WAS FUNCTIONING AS INTENDED. THERE WERE NO BANNER OR DROP OUT ISSUES FOUND ON THE PIC IX, AS WELL AS NO ISSUES FOUND WITH THE WIRELESS SYSTEM DURING EVALUATION. PER THE PHILIPS PRODUCT SUPPORT ENGINEER'S (PSE¿S) FINDINGS, WE HAVE INSUFFICIENT INFORMATION ON THE PIC IX, AS THIS MX40 WAS NOT CONNECTED. PSE CONCLUSION BELOW: EVENT DATE AND TIME: 2/1/2023 AROUND 11 PM. BED LABEL/NUMBER: BED REMT54 "THE LAST TIME THE MX40 HAD A CONNECTION TO PICIX AT 01FEB2023 16:05:09.06, IT ENTERS STANDBY MODE. AFTER THE MX40 WAS TAKEN OUT OF STANDBY AT 01FEB2023 16:10:55.41, IT DID NOT CONNECT TO THE PIC IX. DURING THE REPORTED EVENT 01FEB2023 AROUND 11:00PM THE MX40 HAD NO CONNECTION TO PIC IX AND THE PIC IX WAS TRYING TO CONTACT THE MX40 BY MAC(0009FB46278A) WITHOUT A REPLY; OTHER MX40S WERE CONNECTED TO THE PIC IX DURING THIS TIME. THE NEXT DAY AT 02FEB2023 10:49:50.12, THE MX40 RETURNED INTO AN ASSOCIATED STATE. NO EVIDENCE IF THE MX40 WAS ALL THE TIME SWITCHED ON BETWEEN 01FEB2023 16:11:40.78 AND 02FEB2023 10:49:50.12. MOST PROBABLY, THE BATTERY OF THE MX40 DRAINED DURING THIS TIME WITHOUT CONNECTION TO PIC IX." THE DEVICE WAS CONFIRMED TO BE OPERATING PER SPECIFICATIONS AND NO FAILURE WAS IDENTIFIED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    THE CUSTOMER BIOMEDICAL ENGINEER (BIOMED) REPORTED ON THAT ON (B)(6) "2023" AROUND 11:00PM, A PATIENT WAS FOUND DECEASED FOR AN UNDETERMINED AMOUNT OF TIME. THE BIOMED REPORTED THAT THE WERE GETTING A WEIRD REPEATING MESSAGE IN THE LOGS THAT SAYS "GOING EQUIPMENT ONLINE AND OFFLINE." THE STAFF WAS UNSURE IF TELE SIGNAL LOSS WAS RELATED TO THE PATIENT DEATH; THE STAFF IS NOT SURE IF THE TELEMETRY DEVICE WAS COMMUNICATING WITH THE PHILIPS INFORMATION CENTER IX (PIC IX) AT THE TIME THE PATIENT EXPIRED. THE BIOMED NOTED SEVERAL INCIDENTS OF ALL TELE SIGNALS BEING LOST DURING THE DAY YESTERDAY. THE BIOMED ALSO REPORTED THAT ALL ROOMS (MX40) WHERE SHOWING THE FOLLOW AUDIT LOG MESSAGES: "TELE WEAK SIGNAL", "OFFLINE/ON LINE", "NO DATA TELE.", AND "STANDBY REQUESTED". A PHILIPS REMOTE SERVICE ENGINEER (RSE) CHECKED THE SYSTEM LOGS AND FOUND NO ERRORS FOR PIC IX SURVEILLANCE "S8TELESURV2" AT THE REPORTED TIME; THE RSE DID SEE ERROR PRIOR TO THE REPORTED TIME AND AFTER. ALL ACCESS POINT CONTROLLERS (APCS) WERE IN A CONNECTED STATUS. THE RSE NOTED THAT HE CUSTOMER ALSO HAS 20 ACCESS POINTS (APS) THAT ARE IN AN "OFFLINE" STATUS, AND ALSO FOUND ACCESS SWITCH PCN_C1758_ACCESS_R5 IN AN "OFFLINE" STATUS. THE CUSTOMER UPDATED AND WAS AWARE OF THE AP'S AND ACCESS SWITCH AND ALSO REPORTED THAT THESE ARE NO LONGER BEING USED. A PHILIPS TECHNICAL CONSULTANT (TC) IS BEING DISPATCHED TO THE SITE FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494682 PIC IX HARDWARE PIC IX HARDWARE MHX PHILIPS MEDICAL SYSTEMS 866424

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death