BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACUTE CARE SYSTEM (INCL. M540)

    MDR report key: 5209789 · Received November 9, 2015

    Report

    Report Number
    1220063-2015-00030
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 1, 2015
    Report Date
    January 29, 2016
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K092788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOG FILES OF THE AFFECTED IACS WERE PROVIDED FOR THE INVESTIGATION. THE ECG STRIP REPORTS WERE REQUESTED BUT NOT AVAILABLE FOR FURTHER EVALUATION. THE ANALYSIS OF THE LOG FILES SHOWED THAT DURING THE REPORTED EVENT MULTIPLE MEDIUM GRAD "LOW HEART RATE" ALARMS WERE GENERATED AUDIBLY AND VISUALLY. SCREENSHOTS CONFIRM THAT THE IACS WAS DISPLAYING HEART RATES OF 3 AND 5 BEATS PER MINUTE DURING THESE ALARMS. HOWEVER, THE WAVEFORM BEING DISPLAYED ON THE IACS REVEALS THAT THE ACTUAL HEART RATE OF THE PATIENT WAS MORE THAN 90 BPM. THE CAUSE FOR THE INCORRECTLY DISPLAYED HEART RATE WAS THAT MANY QRS PEAKS OF THE PATIENT DID NOT REACH THE DETECTION THRESHOLD. IN ORDER TO IMPROVE THIS BEHAVIOR THE IACS SOFTWARE VERSION VG 4 ALLOWS USERS TO SET THE QRS DETECTION THRESHOLD. THE USER EXPECTED A "BRADYCARDIA" ALARM, BUT SINCE A HEART RATE OF 3 BPM WAS DISPLAYED AN "ASYSTOLE" ALARM SHOULD BE EXPECTED. THE DEVICE DID NOT ALARM THE EXPECTED "ASYSTOLE" ALARM DUE TO THE CALCULATION STEP ORDER IN THE SOFTWARE. THE IACS INITIALLY DETECTED A HEART RATE WHICH DID NOT MEET THE REQUIREMENTS OF "ASYSTOLE" AND "BRADYCARDIA". AFTER "ASYSTOLE" DETECTION AN ARTIFACT WAS DETECTED AND SOME QRS INTERVALS WERE IDENTIFIED AS A BAD DETECTION. IF A QRS IS FOUND IN ONE LEAD BUT NOT THE OTHER, IT IS CONSIDERED A BAD SIGNAL. THIS IS DONE TO PREVENT BAD SIGNALS FROM ALTERING THE CORRECT HEART RATE. IN ORDER TO IMPROVE THE CALCULATION OF HEART RATES BELOW 15 BPM A SOFTWARE CHANGE HAS BEEN INITIATED. IN ORDER TO IMPROVE QRS DETECTION THE USER IS RECOMMENDED TO INITIATE AN ARRHYTHMIA RELEARN PROCESS TO RELEARN THE PATIENT'S QRS REFERENCE TEMPLATE, CHANGE ECG ELECTRODES DAILY AND UPGRADE TO VG4.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED BUT HAS NOT YET BEEN CONCLUDED. THE INVESTIGATION RESULT WILL BE REPORTED IN THE FOLLOW UP-REPORT.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED WHAT THE NURSING STAFF IDENTIFIED AS A BRADYCARDIA EVENT BUT THE IACS ALARMED ONLY FOR 'LOW HEART RATE' WHICH IS A MEDIUM ALARM. IT REPORTEDLY DID NOT ALARM FOR THE MORE SERIOUS 'BRADY' ALARM. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICES HAVE REPORTEDLY REMAINED IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741390 INFINITY ACUTE CARE SYSTEM (INCL. M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT CBK DRAEGER MEDICAL SYSTEMS, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1