BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX40 WLAN

    MDR report key: 17463339 · Received August 4, 2023

    Report

    Report Number
    1218950-2023-00530
    Event Type
    Death
    Date Received
    August 4, 2023
    Date of Event
    July 4, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    UDI-DI
    00884838030350
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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

    A TECHNICAL INVESTIGATION WAS PERFORMED BY PHILIPS PRODUCT SUPPORT ENGINEERING. IT WAS STATED THAT LOOKING AT THE CLINICAL AUDIT LOGS WE CAN CONFIRM THE VENT FIB ALARM WAS GENERATED AROUND THE TIME MENTIONED. ADDITIONALLY, AFTER REVIEW OF THE PROVIDED PICTURES, CORROSION AT THE CENTERS OF THE BATTERY CONTACTS CAN RESULT IN INCREASED RESISTANCE/IMPACT TO CONNECTION BETWEEN THE DEVICE AND BATTERY. IT WAS ALSO NOTED THAT SOME OF THE BATTERIES BEING USED ARE OVER 4 YEARS OLD. THE PRODUCT IFU STATES THAT THE BATTERY WILL LAST FOR 4 YOURS OR 500 COMPLETE CHARGE/DISCHARGE CYCLES, AS THE BATTERY AGES, CAPACITY CAN DECREASE BY 25 ¿ 30%. IF THIS IS NOT ACCEPTABLE, THE BATTERY SHOULD BE REPLACED AFTER TWO YEARS. EFFORTS WERE MADE TO HAVE THE FAULTY BATTERIES SENT FOR FURTHER EVALUATION BUT WAS NOT SUCCESSFUL. A GFE (GOOD FAITH EFFORT) CONFIRMED THAT THE FAULTY STANDALONE LITHIUM BATTERIES COULD NOT BE SHIPPED EITHER BY AIR OR SEA FREIGHT ACROSS BY ALL CARRIERS CONTACTED. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS CORROSION AT THE CENTERS OF THE BATTERY CONTACTS DUE TO OLD BATTERIES ABOVE THE RECOMMENDED USAGE TIME. THE REPORTED PROBLEM WAS CONFIRMED. 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

    NEW INFORMATION RECEIVED INDICATING THAT THE EVENT INVOLVED A PATIENT DEATH. PHILIPS IS IN PROCESS OF OBTAINING ADDITIONAL INFORMATION. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT CENTRAL UNIT DID NOT ALARM WHEN A PATIENT WENT INTO VF ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812033 INTELLIVUE MX40 WLAN INTELLIVUE MX40 WLAN DSI PHILIPS MEDICAL SYSTEMS 865352 00884838030350

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| R