BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY ACUTE CARE SYSTEM (M540)

    MDR report key: 11836683 · Received May 17, 2021

    Report

    Report Number
    1220063-2021-00017
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 9, 2021
    Report Date
    June 17, 2021
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    MHX
    PMA / PMN Number
    K113798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF THE LOG FILES DURING THE EVENT, IT WAS FOUND THAT ART, SPO2 AND ECG WERE ALL DISCONNECTED. LOW GRADE ALARMS GENERATED FOR ALL THESE DISCONNECTIONS. AS A RESULT, NO ALARMS GENERATED FOR ASY OR LOW HEART RATE AS DESIGNED. THE ECG LEADS WERE RECONNECTED AFTER THE EVENT AND ALARMS THEN STARTED GENERATING FOR LOW HR AND ASY. NO DISCONNECTIONS OR REBOOTS OF THE C500 WERE SEEN IN THE LOG FILES, THEREFORE THE REPORTED BLACK SCREEN COULD NOT BE VERIFIED. SINCE ECG, ART AND SPO2 WERE ALL DISCONNECTED, IT IS POSSIBLE THIS COULD HAVE BEEN INTERPRETED AS A BLACK SCREEN. AFTER REVIEW BY A DRAEGER TECHNICIAN, IT WAS FOUND THAT THE DEVICE ALARMED AS DESIGNED AND FUNCTIONED WITHOUT FAIL. THERE WAS NO DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: OUR MAINTENANCE ENGINEER, (B)(6), WAS CALLED YESTERDAY EVENING BY THE BIOMEDICAL DEPARTMENT OF THE NICE HOSPITAL, ARCHET 2 SITE, TO REPORT THAT THE STC DEPARTMENT HAD DECLARED AN UNDESIRABLE EVENT THAT OCCURRED ON FRIDAY, (B)(6). - THE IACS C500 SCREEN WAS "BLACK" (=OFF?). NO INFORMATION ON THE STATUS OF THE M540 DURING THIS TIME. NOR THE STATUS OF THE LIGHTS (C500, M540, P2500). - NO ALARMS OR TRACINGS FROM 20:06 TO 20:22 (16 MINUTES). - THE PATIENT EXPERIENCED ASYSTOLE DURING THIS TIME. - PATIENT WAS RESUSCITATED BUT APPEARS TO BE BRAIN DEAD SINCE THEN ACCORDING TO BIOMEDICAL (SPECULATION/MEDICAL SECRECY) ON THE PLANT, IT CAN'T GO BACK BEYOND (B)(6) (72H FD). NO ASYSTOLE EVENTS RECORDED ON THE PLANT. FROM 22:22, THE IACS RESUMED NORMAL OPERATION "BY ITSELF" ACCORDING TO THE SERVICE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: OUR MAINTENANCE ENGINEER, (B)(6), WAS CALLED YESTERDAY EVENING BY THE BIOMEDICAL DEPARTMENT OF THE (B)(6) HOSPITAL, ARCHET 2 SITE, TO REPORT THAT THE STC DEPARTMENT HAD DECLARED AN UNDESIRABLE EVENT THAT OCCURRED ON FRIDAY, APRIL 9. THE IACS C500 SCREEN WAS "BLACK" (=OFF?). NO INFORMATION ON THE STATUS OF THE M540 DURING THIS TIME. NOR THE STATUS OF THE LIGHTS (C500, M540, P2500). NO ALARMS OR TRACINGS FROM 20:06 TO 20:22 (16 MINUTES). THE PATIENT EXPERIENCED ASYSTOLE DURING THIS TIME. PATIENT WAS RESUSCITATED BUT APPEARS TO BE BRAIN DEAD SINCE THEN ACCORDING TO BIOMEDICAL (SPECULATION/MEDICAL SECRECY). ON THE PLANT, IT CAN'T GO BACK BEYOND APRIL 11 (72H FD). NO ASYSTOLE EVENTS RECORDED ON THE PLANT. FROM 22:22, THE IACS RESUMED NORMAL OPERATION "BY ITSELF" ACCORDING TO THE SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734490 INFINITY ACUTE CARE SYSTEM (M540) PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT MHX DRAEGER MEDICAL SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S