BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACUTE CARE SYSTEM INCL. M540

    MDR report key: 3820739 · Received April 30, 2014

    Report

    Report Number
    9611500-2014-00035
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2020
    Product Code
    LYC
    PMA / PMN Number
    K092788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE USER WAS OBSERVING AN UNUSUAL DEVICE BEHAVIOR DURING AN INSTANCE OF PATIENT DEATH (WHICH WAS EXPECTED AND NOT THE CONSEQUENCE OF USE OF THE DEVICE). THE CUSTOMER EXPECTED ASYSTOLE ALARMS AT THE INFINITY CENTRAL STATION (ICS) AND COCKPIT BUT INSTEAD RECEIVED BRADYCARDIA ALARMS WHEN THE PATIENT PASSED AWAY. THE CUSTOMER PROVIDED CLINICAL WAVEFORMS CORRESPONDING WITH THE ISSUE, AS WELL AS SOFTWARE LOG FILES, BOTH OF WHICH WERE REVIEWED. IT COULD BE DETERMINED THAT THE ECG ARRHYTHMIA PROCESSING PARAMETER WAS CONFIGURED BY THE USER TO AN ECG 1 & 2 SETTING. WHEN USING A DUAL CHANNEL ECG SELECTION, THE IACS MONITOR WILL DETERMINE THE HEART RATE AND ARRHYTHMIA CONDITIONS BASED ON SIGNALS OBTAINED AT BOTH LEADS IN THE TWO CHANNELS. FROM THE ANALYZED DATA, IT IS EVIDENT THAT ECG LEAD 1 HAS REGISTERED AN ASYSTOLIC SIGNAL, HOWEVER ECG LEAD 2 REGISTERED A VALID BRADYCARDIA RHYTHM SIGNAL. IF TWO CHANNELS HAVE BEEN SELECTED NO ASYSTOLE ALARM IS BEING EXECUTED AS LONG AS ONE OF THE CHANNELS DETECTS A VALID SIGNAL. AS A RESULT, THE MONITOR POSTED A SERIOUS GRADE BRADYCARDIA ALARM TO USER AT THE COCKPIT AND INFINITY CENTRAL STATION (ICS). THE SCREEN SHOT OF THE INFINITY CENTRAL STATION ICS ONE MINUTE AFTER DEATH OF PATIENT HAS BEEN MADE AVAILABLE (ATTACHMENT). THE PICTURE SHOWS THAT STILL SINGLE RHYTHM SIGNALS EXISTED. THE FREQUENCY HAS BEEN REGISTERED WITH 19/MINUTE, WHAT IS JUST ABOVE THRESHOLD FOR ASYSTOLE ALARM (15BPM). IT IS LIKELY THAT EVEN THOUGH THE PATIENT HAS DIED SHORT TIME BEFORE THERE WAS STILL A SMALL AMOUNT OF HEART ACTIVITY THAT HAS BEEN PICKED UP BY THE ECG LEADS. IN THIS CASE, AN ASYSTOLE ALARM WOULD HAVE BEEN DISPLAYED IF THE ECG ARRHYTHMIA PROCESSING PARAMETER WAS SET ONLY TO ECG1, A SINGLE CHANNEL SELECTION FOR ARRHYTHMIA MONITORING. THERE IS NO ISSUE WITH THE DEVICE WHICH WOULD REQUIRE REPAIR OR CORRECTION; IT HAS FUNCTIONED AS DESIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IN CRITICAL CONDITION AND DIED DESPITE SEVERAL MEDICAL INTERVENTION WAS PERFORMED. THE USE WAS AWARE OF THE PT STATUS BUT NOTICED ON THE OTHER HAND THAT THE MONITOR WAS ONLY ALARMING FOR BRADYCARDIA AND NOT AS EXPECTED FOR ASYSTOLE.

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP REPORT TO 9611500-2014-00035. DURING AN INTERNAL DATA BASE ANALYSIS WAS DETERMINED THAT - UPON CLOSURE OF THE COMPLAINT RECORD - NO FOLLOW-UP WAS FILED TO THE FDA, ACCIDENTALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259525 INFINITY ACUTE CARE SYSTEM INCL. M540 PATIENT MONITOR, MULTI-PARAMETER LYC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death