BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 15528340 · Received October 3, 2022

    Report

    Report Number
    1220063-2022-00016
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    September 1, 2022
    Report Date
    November 17, 2022
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    UDI-DI
    04049098009799
    PMA / PMN Number
    K113798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DATE/TIME FOR WHEN THE PASUE ALARM WAS EXPECTED WAS SPECIFIED AS 13:37 ON (B)(6) 2022. THE HOSPITAL BIOMED TESTED THE INVOLVED M540 WITH NO MALFUNCTIONS IDENTIFIED. REVIEW OF THE M540 EVENT LOGS SHOW THAT ¿ACCELERATED IDIOVENTRICULAR RHYTHM¿ (AIVR) AND ¿HR < 50¿ ALARMS WERE ISSUED AT 13:37. THE ICS LOGS SHOW THE USER SELECTED ALARM SILENCE FOR THE ICS AT 13:36 AND INITIATED AUDIO PAUSE FOR BED LABEL CLCCU08 AT 13:37. THE IACS INSTRUCTIONS FOR USE (IFU) SHOWS THE PAUSE ALARM IS GENERATED BASED ON THE TIME BETWEEN TWO NORMAL OR PVC (V) BEATS, WITH AN INTERVAL >/= THE SELECTED PAUSE RATE. THE PAUSE RATE SELECTED IN THIS CASE WAS REPORTED AS 3 SECONDS. THE PROVIDED ECG EVENT STRIP REPORT WAS REVIEWED BY THE ALGORITHM TEAM, AND IT WAS CONFIRMED THAT THE CRITERIA FOR A PAUSE ALARM WAS NOT MET DURING THE EVENT. THE ADVANCED ARRHYTHMIA MONITORING MODE ALGORITHM CLASSIFIES EACH BEAT DETECTED AS: NORMAL (N), VENTRICULAR ECTOPIC (V [PVC]), SUPRAVENTRICULAR ECTOPIC (S), FUSION (F), OR AN UNKNOWN (Q). WHEN A BEAT IS CLASSIFIED AS Q, THIS MAY BE UPDATED BASED ON SUBSEQUENT BEATS. DURING THE TIME IN QUESTION, THERE WAS A NORMAL BEAT FOLLOWED BY TWO BEATS CLASSIFIED AS Q, THEN ONE AS A V. BASED ON THE 3RD BEAT BEING IDENTIFIED AS V, THE PREVIOUS TWO BEATS WERE UPDATED FROM Q TO V. AS 3 BEATS IN A ROW WERE CLASSIFIED AS PVCS (V BEATS) [WITH A RATE LESS THAN THE VTACH RATE], AN AIVR ALARM WAS PROVIDED. AS THE 3 SECONDS IN QUESTION WAS MEASURED BETWEEN A NORMAL AND A QUESTIONABLE BEAT, THE CRITERIA WAS NOT MET FOR A PAUSE ALARM. THERE WAS NO MALFUNCTION, THE DEVICE WAS WORKING AS DESIGNED AND SPECIFIED IN THE IFU. SEE B6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRAEGER INFINITY ACUTE CARE SYSTEM (IACS) AND ASSOCIATED INFINITY CENTRAL STATION (ICS) FAILED TO PROVIDE AN ALARM FOR AN ECG 3SEC CARDIAC PAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRAEGER INFINITY ACUTE CARE SYSTEM (IACS) AND ASSOCIATED INFINITY CENTRAL STATION (ICS) FAILED TO PROVIDE AN ALARM FOR AN ECG 3SEC CARDIAC PAUSE. THE IACS INCLUDES AN INFINITY MEDICAL COCKPIT PAIRED WITH AN INFINITY M540 BEDSIDE MONITOR. IN THIS CASE, THE IACS WAS BEING USED IN CONJUNCTION WITH THE ICS CENTRAL MONITORING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2384198 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT MHX DRAEGER MEDICAL SYSTEMS, INC MS25520 04049098009799

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown