BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 20266631 · Received September 20, 2024

    Report

    Report Number
    1218950-2024-00666
    Event Type
    Death
    Date Received
    September 20, 2024
    Date of Event
    August 8, 2024
    Report Date
    October 25, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    UDI-DI
    00884838082236
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) REVIEWED THE PROVIDED LOGS AND DETERMINED THAT THE PIC IX WAS FUNCTIONING AS SPECIFIED/CONFIGURED. THERE ARE VARIOUS INSTANCES WHERE THE DEVICE HAS ENTERED STANDBY MODE. BUT EVERY TIME, THE REQUEST TO ENTER STANDBY MODE WAS INITIATED FROM THE PIC MANAGE PATIENT SCREEN AND NOT FROM THE MX40 DEVICE. THE AUDIT LOGS (AUDIT LOGS) AND PIC LOG VIEWER DATA (LOG VIEWER) CLEARLY INDICATES THAT THE DEVICE WAS PUT ON STANDBY FROM THE MANAGE PATIENT WINDOW ON PIC. BASED ON THE INFORMATION PROVIDED, THE MX40 WAS FUNCTIONING AS SPECIFIED/CONFIGURED. MANUFACTURE DATE WAS CORRECTED FROM 03/27/2024 TO 05/23/2013. THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016; THEREFORE, NO UDI IS REQUIRED.

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE PATIENT INFORMATION CENTER IX, CATALOG # 866389, SERIAL # (B)(6) IN USE DURING THIS EVENT IS REPORTED IN MFR 1218950-2024-00652.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CENTRAL MONITORING TECHNICIAN PLACED THE TELEMETRY DEVICE IN STANDBY AT THE REQUEST OF THE FLOOR STAFF; HOWEVER, THE USER INDICATED THE DEVICE CAME OUT OF STANDBY, ALARMED FOR ALL LEADS OFF AND THEN RETURNED TO STANDBY WITHOUT USER INTERVENTION. THIS BEHAVIOR OCCURRED MULTIPLE TIMES BETWEEN 2040 AND THE DISCOVERY OF THE PATIENT BEING UNRESPONSIVE AT 0045. THE PATIENT LATER PASSED AWAY. IT REMAINS UNKNOWN WHEN THE USER CHANGED THE MONITORING MODE FROM STANDBY TO ACTIVE MONITORING. GOOD FAITH EFFORTS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801515 MX40 1.4 GHZ SMART HOPPING MX40 1.4 GHZ SMART HOPPING DSI PHILIPS MEDICAL SYSTEMS 865350 00884838082236

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Death