BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDI CATHETER ENFIT 6FR/49 CM, 5PCS

    MDR report key: 24243471 · Received February 3, 2026

    Report

    Report Number
    8010042-2026-0000137
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    January 6, 2026
    Report Date
    February 3, 2026
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    PIF
    UDI-DI
    17325710004606
    PMA / PMN Number
    K153688
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS CLAIMED THAT DURING VENTILATOR TREATMENT IN NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE, AN ALARM FOR EDI CATHETER ERROR WAS GENERATED. THE PATIENT DESATURATED TO 50% AND BECAME BRADYCARDIC. THE EDI CATHETER WAS REPLACED, AND THE PATIENT STABILIZED. THE EDI CATHETER WAS IN PLACE FOR LESS THAN ONE HOUR. AFTER REPLACEMENT, VENTILATION IN NAVA MODE CONTINUED. NEITHER THE EDI CATHETER NOR THE LOGS FROM THE CONNECTED VENTILATOR HAVE BEEN AVAILABLE FOR FURTHER EVALUATION. A REVIEW OF MANUFACTURING RECORDS FOR THE STATED BATCH NUMBER CONFIRMED THAT ALL MANUFACTURING PARAMETERS WERE WITHIN SPECIFIED LIMITS. ACCORDING TO THE USER¿S MANUAL, THE RECOMMENDED ACTION FOR THE GENERATED ALARM FOR EDI CATHETER ERROR IS TO REPLACE THE EDI CATHETER. DUE TO THE LACK OF THE REPLACED EDI CATHETER AND VENTILATOR LOGS, THE ROOT CAUSE OF THE GENERATED ALARM FOR EDI CATHETER ERROR HAS NOT BEEN CONCLUSIVELY ESTABLISHED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING VENTILATOR TREATMENT IN NAVA (NEURALLY ADJUSTED VENTILATORY ASSIST) MODE, AN ALARM FOR EDI CATHETER FAILURE WAS GENERATED. THE PATIENT DESATURATED TO 50% AND BECAME BRADYCARDIC. THE EDI CATHETER WAS REPLACED, AND THE PATIENT STABILIZED. FINAL PATIENT OUTCOME WAS NO HARM. MANUFACTURER¿S REF #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308847 EDI CATHETER ENFIT 6FR/49 CM, 5PCS GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS PIF MAQUET CRITICAL CARE AB 6883898 3000493558 17325710004606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening