BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDI CATHETER ENFIT 6FR/50 CM, 5PCS

    MDR report key: 24374387 · Received February 18, 2026

    Report

    Report Number
    8010042-2026-0000237
    Event Type
    Death
    Date Received
    February 18, 2026
    Date of Event
    February 4, 2026
    Report Date
    February 18, 2026
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    UDI-DI
    17325710015336
    PMA / PMN Number
    K153688
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION FROM THE HEALTHCARE FACILITY HAS BEEN PROVIDED AND TOGETHER WITH THE INITIAL EVENT DESCRIPTION THE EVENT, AS DESCRIBED, INVOLVED A NEONATAL PATIENT WHO EXPIRED WHILE SUPPORTED ON A SERVO-N VENTILATOR OPERATING IN NIV NAVA MODE WITH AN EDI CATHETER ENFIT IN USE. THE EVENT INVOLVED REPORTS OF PERSISTENT ¿EDI SIGNAL INTERFERENCE FROM ECG¿ ALARMS OVER APPROXIMATELY 24 ¿ 36 HOURS PRIOR TO THE PATIENT¿S DEATH. THE REPORTED ALARM GENERATED ¿EDI SIGNAL INTERFERENCE FROM ECG¿ IS A MEDIUM PRIORITY ALARM INDICATING THAT BACKUP SAFETY VENTILATION IS ACTIVE DUE TO INTERFERENCE FROM THE ECG SIGNAL. THE RECOMMENDED ACTION IS TO CHECK THE EDI CATHETER POSITION. THE ALARM IS BOTH VISUAL AND AUDIBLE AND IS AUTOMATICALLY RESET ONCE THE ALARM CONDITION CEASES. DURING THIS TIME, THE CUSTOMER REPLACED THE EDI CATHETER, EDI CABLE, AND EDI MODULE, AND PERFORMED MULTIPLE CATHETER REPOSITIONING ATTEMPTS. WHEN THE EDI SIGNAL QUALITY WAS COMPROMISED, THE VENTILATOR APPROPRIATELY TRANSITIONED TO BACKUP VENTILATION AS DESIGNED. BACKUP VENTILATION IS A SAFETY FEATURE AND THERE IS NO EVIDENCE THAT BACKUP VENTILATION FAILED OR DELIVERED UNSAFE PRESSURES. CLINICAL SUPPORT FROM GETINGE WAS PROVIDED REMOTELY AND ON-SITE. NO EVIDENCE OF VENTILATOR MALFUNCTION WAS IDENTIFIED. THE VENTILATOR ALARMS AND BACKUP VENTILATION FUNCTIONED AS INTENDED. NO DEVICE FAILURE, DAMAGE, OR DEFECT WAS IDENTIFIED WITH THE EDI CATHETER. THE EDI CATHETER WAS INITIALLY PLACED AT A DEPTH THAT MAY NOT HAVE BEEN OPTIMAL FOR THE PATIENT¿S SIZE. POSSIBLY TOO DEEP AND LATER COILED IN THE STOMACH. THE ECG INTERFERENCE WAS POSSIBLY DUE TO THIS SUBOPTIMAL ELECTRODE POSITION. THE EDI CATHETER OF THE SIZE 6FR/50 CM WAS SUBSEQUENTLY REPLACED WITH AN APPROPRIATELY SIZED EDI CATHETER (6FR/49 CM) BASED ON THE PATIENT¿S WEIGHT, AND PLACEMENT WAS OPTIMIZED USING STANDARD MEASUREMENT TECHNIQUES (NOSE¿EARLOBE¿XIPHOID (NEX)). FOLLOWING REPLACEMENT, EDI SIGNALS WERE REPORTED TO BE WITHIN ACCEPTABLE RANGES. SHORTLY AFTER THESE INTERVENTIONS, THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST AND DID NOT SURVIVE RESUSCITATIVE EFFORTS. THERE IS NO ALLEGATION FROM THE CLINICAL STAFF INVOLVED IN THE PATIENT¿S CARE THAT THE VENTILATOR OR EDI CATHETER IN ANY WAY CONTRIBUTED TO THE PATIENT¿S DEATH. AFTER ADDITIONAL CONTACT, THE RT NICU CLINICAL SPECIALIST AT THE HEALTHCARE FACILITY STATED THAT NO AUTOPSY WAS BEING PERFORMED AND NO ADDITIONAL INFORMATION IS AVAILABLE OR WILL BE PROVIDED REGARDING CAUSE OF DEATH. THE SUBJECTED SINGLE USE EDI CATHETER WAS DISCARDED BY THE HEALTHCARE FACILITY AFTER REMOVAL. NO ABNORMALITIES WERE NOTED WHEN IT WAS REMOVED. THE CONNECTED VENTILATOR HAD A PRE-USE CHECK SUCCESSFULLY PERFORMED AFTER THE EVENT AND WAS RETURNED TO CLINICAL USE ON ANOTHER PATIENT THE DAY AFTER. X-RAY IMAGES WERE PROVIDED BY THE HEALTHCARE FACILITY, WITH THEIR OWN ASSESSMENT THAT THE EDI CATHETER MAY HAVE BEEN PLACED TOO DEEPLY AND WAS IN CONTACT WITH THE STOMACH WALL. OUR INTERNAL MEDICINE PROFESSIONAL REVIEWED THE X-RAY IMAGES AND AGREED WITH THE ASSESSMENT THAT THE EDI CATHETER WAS PLACED TOO DEEPLY AND HAD COILED AGAINST THE STOMACH WALL (CURVATURA MAJOR). THERE IS NO INDICATION THAT THE SUBJECT DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATIONS OR OTHERWISE DID NOT PERFORM AS INTENDED. NO CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE PATIENT¿S DEATH HAVE BEEN ESTABLISHED.

    Description of Event or Problem · 0

    MANUFACTURER'S REF #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEONATAL PATIENT EXPIRED WHILE SUPPORTED ON A VENTILATOR IN NIV NAVA MODE WITH AN EDI CATHETER ENFIT IN USE. PERSISTENT EDI SIGNAL INTERFERENCE FROM ECG ALARMS WERE REPORTED, AND TROUBLESHOOTING INCLUDED CATHETER REPLACEMENT AND REPOSITIONING, WITH BACKUP VENTILATION FUNCTIONING AS DESIGNED. SHORTLY THEREAFTER, THE PATIENT EXPERIENCED CARDIOPULMONARY ARREST AND DID NOT SURVIVE RESUSCITATIVE EFFORTS. A CAUSAL RELATIONSHIP BETWEEN THE EDI CATHETER AND THE REPORTED DEATH HAS NOT BEEN ESTABLISHED. MANUFACTURER¿S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435425 EDI CATHETER ENFIT 6FR/50 CM, 5PCS GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB 6893274 17325710015336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death SERVO-N, SERIAL# (B)(6).