BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 17248667 · Received July 3, 2023

    Report

    Report Number
    1218950-2023-00455
    Event Type
    Death
    Date Received
    July 3, 2023
    Date of Event
    June 2, 2023
    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
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLINICAL SPECIALIST REVIEWED THE AVAILABLE AUDIT LOGS PROVIDED WHICH SHOWED ALARMS FOR BOTH PHYSIOLOGICAL LIMIT VIOLATIONS WHICH WERE ACKNOWLEDGED AND ECG LEADS OFF TECHNICAL INOPS. WHILE THE DEVICE WAS CONNECTED TO THE NETWORK/PIC IX, ALARMS WERE BEING PROVIDED FOR PHYSIOLOGICAL AND TECHNICAL ALARM CONDITIONS. LOST CONNECTIVITY WITH THE NETWORK/PIC IX COULD NOT BE DETERMINED WITH THE AVAILABLE DATA. ADDITIONAL INFORMATION WAS LATER SUPPLIED BY THE FIELD SERVICE ENGINEER. A PHILIPS PRODUCT SUPPORT ENGINEER REVIEWED THE AVAILABLE LOG INFORMATION. THE AUDIT LOG SHOWS THAT THE DEVICE WAS GOING ONLINE AND OFFLINE CONTINUOUSLY DURING THE INCIDENT TIMEFRAME. WHILE THE DEVICE WAS CONNECTED TO THE NETWORK/PIC IX, ALARMS WERE BEING PROVIDED AT THE PIC IX, AND USERS WERE ACKNOWLEDGING THE ALARMS. WHEN THE MX40 WAS DISCONNECTED FROM THE PIC IX, A ¿NO DATA TELE¿ TECHNICAL INOP (VISUAL/AUDIBLE ALARMS) AT THE SECTOR OF THE PIC IX AND THE MX40 WOULD HAVE BEEN IN MONITOR MODE (PROVIDING ALARMS AT THE DEVICE AS APPROPRIATE). THE MX40 PWM LOGS WERE NOT CAPTURED FOR REVIEW PRIOR TO THE DEVICE BEING RETURNED TO BENCH REPAIR AND THE RFDA LOG DATA CAPTURED STARTED ON 03-JUL-2023 (WELL BEYOND THE INCIDENT DATE). THE DEVICEDEBUG LOG DATA CAPTURED INDICATES THERE WAS A BATTERY CHANGE AT 23:31 ON 01-JUN-2023. BASED ON BATTERY VOLTAGE AT BOOT-UP, AA BATTERIES AND THE BATTERY ADAPTER TRAY WERE BEING USED. THE DEVICEDEBUG LOG ALSO SHOWS ONGOING DISCONNECTS/FAILURES TO CONNECT WITH AN ACCESS POINT FROM 15:54 ON 02-JUN-2023 THROUGH 17:58 ON 02-JUN-2023. THE DISCONNECTS APPEAR TO BE RELATED TO MARGINAL TO POOR SIGNAL STRENGTH (WITH SOME EXCEPTIONS). MX40 UNSUCCESSFULLY ATTEMPTING TO CONNECT TO NETWORK. RECOMMEND PERFORMING A COVERAGE AREA VERIFICATION TO DETERMINE IF THERE IS AN ISSUE WITH THE ACCESS POINT OR COVERAGE (PROPER OVERLAP OF AP ZONES OR IF THERE IS SOME OTHER INTERFERENCE/OBSTRUCTION ON THE AREA OF USE. THE ENGINEER PROVIDED THEIR ANALYSIS FINDINGS. IT WAS RECOMMENDED PERFORMING A COVERAGE AREA VERIFICATION TO DETERMINE IF THERE IS AN ISSUE WITH THE ACCESS POINT OR COVERAGE (PROPER OVERLAP OF AP ZONES OR IF THERE IS SOME OTHER INTERFERENCE/OBSTRUCTION ON THE AREA OF USE. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WOULD LIKE TO HAVE THE TELE MX40 CHECKED, AS THE DEVICE WAS INVOLVED IN A PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20924 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 Female Death