BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIVUE MX40 2.4GHZ

    MDR report key: 20631559 · Received November 7, 2024

    Report

    Report Number
    1218950-2024-00793
    Event Type
    Death
    Date Received
    November 7, 2024
    Date of Event
    October 23, 2024
    Report Date
    January 31, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K113125
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: THE DEVICE WAS RECEIVED FOR TESTING WITHOUT THE BATTERY ORIGINALLY USED. TESTING OF THE DEVICE WITH A NEW BATTERY WAS PERFORMED TOGETHER WITH THE FINNISH SAFETY INVESTIGATION AUTHORITY (OTKES). A VISUAL INSPECTION WAS PERFORMED AND IT WAS FOUND THAT THE DEVICE SHOWED PHYSICAL DAMAGE. THE BATTERY DOOR HINGE ON THE LEFT SIDE HAS BEEN BROKEN OFF AND ADDITIONALLY THE ¿PIN¿ THAT HOLDS THE BATTERY ON THE BATTERY COMPARTMENT HAS BEEN BROKEN OFF. IT WAS QUITE EASY TO DISLODGE THE BATTERY DURING TESTING, A ¿SMALL¿ TAP OR "A CLAP OF HANDS" WAS NEEDED TO GET THE BATTERY DISLOCATED FROM THE MX40. AS STATED WITHIN THE RELATED INSTRUCTIONS FOR USE (IFU), RELEASE C.01, CHAPTER 4: BASIC OPERATION: ¿ON A DAILY BASIS, THE CLINICIAN SHOULD INSPECT THE MX40 AND ACCESSORIES. REPLACE ANY DAMAGED EQUIPMENT OR ACCESSORIES.¿ FURTHER TESTING WAS PERFORMED WHICH REVEALED, THAT THE MX40 WAS OPERATING NORMALLY DURING THE DAY. A DEMO SYSTEM SET UP WAS MADE AND THE MX40 WAS CONNECTED TO IT FOR ROUND ABOUT 6 HOURS. DURING THAT TIME THE MX40 WAS REBOOTED SEVERAL TIMES AND EVERY TIME IT BOOTED UP NORMALLY. FURTHERMORE, IT WAS POSSIBLE TO WALK AROUND WITH THE MX40 WITH A SIMULATOR ATTACHED TO IT. NO PROBLEMS WERE FOUND DURING THIS TESTING. ADDITIONALLY, IT WAS ALSO TESTED HOW FAR THE DEVICE COULD BE TAKEN AWAY FROM THE ACCESS POINT (AP). IT TURNED OUT THAT A WALK ABOUT 30+ METERS AND AROUND THE CORNER WAS NEEDED, UNTIL IT DISCONNECTED FROM THE AP (IN AN OPEN SPACE). FURTHERMORE, THE LOGS WERE GATHERED AND FORWARDED TO PRODUCT SUPPORT ENGINEERING (PSE) FOR ANALYSIS. DURING REVIEW OF THE LOGS BY PSE AND THE INVOLVED FIELD SERVICE ENGINEER (FSE), IT WAS FOUND THAT THE CUSTOMER WAS USING A BATTERY, THAT HAD EXCEEDED THE MAXIMUM CHARGE CYCLES. AS DESCRIBED IN THE IFU, RELEASE C.01, CHAPTER 5: ALARMS, THE LITHIUM-ION BATTERY MUST BE REPLACED WHEN EXCEEDED THE MAXIMUM CHARGE CYCLE LIMIT AND REACHED THE END OF IT'S USEFUL LIFE. IN ADDITION, IT WAS FOUND THAT A "TELE SERVICE BATT" INOP WAS GENERATED, WHICH SUPPRESSED THE "TELE BATTERY LOW" INOP. AS DESCRIBED IN THE IFU, RELEASE C.01, CHAPTER 5: ALARMS: TELE SERVICE BATT NOTE - WHEN THE ABOVE INOP OCCURS, THE TELE BATTERY LOW INOP IS SUPPRESSED. THE INVESTIGATION REVEALED THAT POSSIBLE CAUSES FOR THE REPORTED ISSUE COULD BE THAT EITHER THE BATTERY LOST CONTACT (BECAUSE OF BROKEN CLIPS AND BATTERY COMPARTMENT) OR THE BATTERY POWER DROPPED (BECAUSE THE BATTERY WAS OLD AND ALREADY ABOVE 500 CHARGE CYCLES). HOWEVER, BASED ON THE TESTING PERFORMED AND THE INFORMATION AVAILABLE, THE EXACT CAUSE FOR THE REPORTED ISSUE REMAINS UNKNOWN. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE EXACT CAUSE OF THE REPORTED ISSUE IS UNKNOWN. THE REPORTED PROBLEM WAS NOT CONFIRMED. BASED ON THE INFORMATION AVAILABLE AND THE TESTING PERFORMED, THE EXACT CAUSE FOR THE REPORTED ISSUE COULD NOT BE ESTABLISHED. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    D4: THE MANUFACTURING DATE FOR THE REPORTED DEVICE IS PRIOR TO 24SEPT2016 SO NO UDI REQUIRED. (B)(6). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT PASSED AWAY DUE TO POTENTIAL TELEMETRY ISSUES. THE USER ROUNDED ON THE PATIENT WITH THE PHYSICIAN AT 0950 AND FOUND THE PATIENT UNRESPONSIVE. THE PATIENT'S RHYTHM WAS ASYSTOLE AND A CODE TEAM WAS CALLED TO THE BEDSIDE, BUT RESUSCITATION WAS UNSUCCESSFUL. A NURSE SAW THE PATIENT ALIVE AROUND 0830 AND TELEMETRY STOPPED DISPLAYING AT 0901. ALL ECG WIRES WERE ATTACHED TO THE PATIENT AND THE BATTERY WAS IN PLACE, WITH NO LOW BATTERY ALARM BEING NOTED BY NURSING STAFF. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS A REPORT OF PATIENT OR USER HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT PASSED AWAY DUE TO POTENTIAL TELEMETRY ISSUES. THE USER ROUNDED ON THE PATIENT WITH THE PHYSICIAN AT 0950 AND FOUND THE PATIENT UNRESPONSIVE. THE PATIENT'S RHYTHM WAS ASYSTOLE AND A CODE TEAM WAS CALLED TO THE BEDSIDE, BUT RESUSCITATION WAS UNSUCCESSFUL. A NURSE SAW THE PATIENT ALIVE AROUND 0830 AND TELEMETRY STOPPED DISPLAYING AT 0901. ALL ECG WIRES WERE ATTACHED TO THE PATIENT AND THE BATTERY WAS IN PLACE, WITH NO LOW BATTERY ALARM BEING NOTED BY NURSING STAFF. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS HAVE BEEN INITIATED. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS A REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612715 INTELLIVUE MX40 2.4GHZ INTELLIVUE MX40 2.4GHZ DSI PHILIPS MEDICAL SYSTEMS 865351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death