BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-I

    MDR report key: 5233796 · Received November 18, 2015

    Report

    Report Number
    8010042-2015-01067
    Event Type
    Injury
    Date Received
    November 18, 2015
    Report Date
    October 23, 2015
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PARTS OR LOGS WERE RETURNED THEREFORE THE INVESTIGATION CONSISTS OF AN EVALUATION OF THE PICTURE AND INFORMATION THAT WAS CONTAINED IN THE ARTICLE. THE SUMMARIZED EDI SIGNAL LOOKED GOOD BUT, OBVIOUSLY IT WAS NOT SHOWING THE EDI ACTIVITY FROM THE CORRECT POSITION IN THE ESOPHAGUS/STOMACH. IT WAS TAKING UP THE DIAPHRAGM SIGNAL FROM THE OUTER CORNER OF THE THORAX SEEN IN THE X-RAY PICTURE AFTERWARDS, WHERE THERE ARE ACTUALLY MUSCLES WHICH ALSO SEND OUT EDI ACTIVITY, AS ALL MUSCLES DO. THE REMARK BY THE AUTHOR THAT IT LOOKED LIKE A NORMAL EDI SIGNAL IS TRUE FOR THE SUMMARIZED SIGNAL SHOWN BELOW THE 4 LEADS BUT, THE 4 LEADS WERE CLEARLY NOT NORMAL, THEY DID NOT SHOW A NORMAL PROPAGATION OF THE P-WAVES FROM BEING HIGH IN THE UPPER LEADS AND NEGATIVE, OR ZERO, WHEN THE CATHETER IS IN THE STOMACH. THEY ALSO HAD A LOT OF DISTURBANCES SHOWING THAT THE EDI CATHETER WAS NOT POSITIONED CORRECTLY. THE CAUSE OF THE PROBLEM WAS THAT THEY DID NOT FULLY UNDERSTAND THE DISPLAYED CURVES. THE USER WAS MISLED BY THE HIGH-LIGHTENING IN PINK OF THE SECOND AND THIRD LEADS AND THE SUMMARIZED EDI SIGNAL WHICH WAS DISPLAYED AS A NORMAL EDI SIGNAL. THE OTHER VERIFICATION METHOD USED, WHERE A SUCTION HOSE WAS CONNECTED TO THE EDI CATHETER, SHOULD HAVE RESULTED IN ASPIRED ACIDIC LIQUID/FLUID IF THE EDI CATHETER WAS CORRECTLY POSITIONED. THEREFORE, BY NOT GETTING ANY LIQUID/FLUIDS BACK, THE USER COULD NOT DETERMINE THAT THE EDI CATHETER WAS IN THE CORRECT POSITION AND THUS AN X-RAY SHOULD HAVE BEEN DONE TO DECIDE THE CORRECT POSITION WAS ESTABLISHED BEFORE USE.

    Additional Manufacturer Narrative · 1

    NOVEMBER 18 2015 11:20 AM (GMT-5:00) ADDED BY (B)(6): FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IN AN ARTICLE, DOI 10.1007/S00134-015-3981-0, IN THE JOURNAL INTENSIVE CARE MEDICINE, IT WAS STATED THAT USER CAN BE MISLED BY EDI SIGNAL FOR CORRECT PLACEMENT OF THE EDI CATHETER. IN THIS ARTICLE THE POSITIONING OF EDI CATHETER WAS INCORRECT. AFTER PLACEMENT OF THE EDI CATHETER, NAVA AND ENTERAL TUBE FEEDING WERE STARTED. THERE AFTER THE PATIENT'S RESPIRATORY SITUATION DETERIORATED. A CHEST X-RAY THAT WAS PERFORMED AFTERWARDS SHOWED THAT THE EDI CATHETER WAS SITUATED IN THE RIGHT INTRAPLEURAL COSTOPHERIC SINUS. THE PATIENT GOT HYDROPENOUTHORAX BUT WAS TRANSIENT. THE PATIENT DIED 74 DAYS LATER BUT THIS HAD NOTHING TO DO WITH THE PLACEMENT OF THE EDI CATHETER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763702 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening