BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX40 1.4 GHZ SMART HOPPING

    MDR report key: 17754929 · Received September 15, 2023

    Report

    Report Number
    1218950-2023-00654
    Event Type
    Death
    Date Received
    September 15, 2023
    Date of Event
    August 18, 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
    ME, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS IS IN PROCESS OF OBTAINING ADDITIONAL INFORMATION. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INSPECTION OF THE DEVICE BY THE PHILIPS FIELD SERVICE PERSONNEL AND CLINICAL ENGINEERING REVEALED FLUID INTRUSION IN THE BATTERY TRAY. PRODUCT SUPPORT ENGINEER STATED THE BATTERY ADAPTER TRAY SHOWS WEAR AND SOME SEPARATION OF THE FLEX CIRCUIT FROM THE TRAY & BATTERY COMPARTMENT SHOWS CHEMICAL RESIDUE. THE COMPLAINT WAS ESCALATED FOR TECHNICAL INVESTIGATION AND THE RESULTS INDICATE THAT THE DEVICE WENT OFFLINE DUE TO SOME TYPE OF BATTERY INTERRUPTION. DURING THIS TIME, A ¿NO DATA TELE¿ TECHNICAL INOP WOULD HAVE BEEN DISPLAYED IN THE PATIENT SECTOR AND AN AUDIBLE TONE WOULD HAVE BEEN PROVIDED. THE DEVICE WENT BACK ONLINE AT 04:49 ON 18-AUG-2023 WHEN BATTERIES WERE REPLACED. THE BATTERY ADAPTER TRAY SHOWS WEAR AND SOME SEPARATION OF THE FLEX CIRCUIT FROM THE TRAY, BUT THIS IS NOT SIGNIFICANT ENOUGH TO PREVENT THE DEVICE FROM FUNCTIONING. THE PICTURE OF THE INSIDE OF THE BATTERY COMPARTMENT SHOWS CHEMICAL RESIDUE. THERE DOES NOT APPEAR TO BE ENOUGH RESIDUE TO PREVENT CONTACT WITH THE BATTERY ADAPTER TRAY. IT WAS ALSO NOTED THAT THE MX40 WAS TESTED BY THE PHILIPS TECHNICAL CONSULTANT WHO WAS ON SITE AND THE DEVICE WAS OPERATION AFTER THE EVENT, NO ISSUES WERE FOUND, BUT THIS WAS AFTER THE DEVICE WAS CLEANED AND BATTERY TRAY REPLACED BY THE BIOMED. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS DUE TO SOME TYPE OF BATTERY INTERRUPTION. THE REPORTED PROBLEM WAS CONFIRMED. THE PRODUCT SUPPORT ENGINEER PROVIDED THEIR ANALYSIS FINDINGS. REVIEW OF THE LOG INFORMATION PROVIDED INDICATES THAT THE DEVICE WENT OFFLINE DUE TO SOME TYPE OF BATTERY INTERRUPTION. DURING THIS TIME, A ¿NO DATA TELE¿ TECHNICAL INOP WOULD HAVE BEEN DISPLAYED IN THE PATIENT SECTOR AND AN AUDIBLE TONE WOULD HAVE BEEN PROVIDED. THE DEVICE WENT BACK ONLINE AT 04:49 ON 18-AUG-2023 WHEN BATTERIES WERE REPLACED. THE PICTURE OF THE INSIDE OF THE BATTER COMPARTMENT SHOWS CHEMICAL RESIDUE. THERE DOES NOT APPEAR TO BE ENOUGH RESIDUE TO PREVENT CONTACT WITH THE BATTERY ADAPTER TRAY. IT WAS ALSO NOTED THAT THE MX40 WAS TESTED BY THE PHILIPS TECHNICAL CONSULTANT WHO WAS ON SITE AND THE DEVICE WAS OPERATION AFTER THE EVENT, NO ISSUES WERE FOUND, BUT THIS WAS AFTER THE DEVICE WAS CLEANED AND BATTERY TRAY REPLACED BY THE BIOMED. 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 REPORTED THE DEVICE WAS DROPPING TELE SIGNAL. ALLEGEDLY DID NOT ALARM CLINICAL STAFF. A PATIENT DEATH WAS REPORTED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331017 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 89 YR Male Death