BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAR

    MDR report key: 22705315 · Received August 4, 2025

    Report

    Report Number
    9680661-2025-00004
    Event Type
    Injury
    Date Received
    August 4, 2025
    Date of Event
    July 8, 2025
    Report Date
    August 4, 2025
    Manufacturer
    COVIDIEN
    Product Code
    BSY
    UDI-DI
    10884521822894
    PMA / PMN Number
    K031997
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE INSTALLATION OF A CLOSED SUCTION SYSTEM SEVERAL LEAKS WERE OBSERVED ON THE FAN SIDE DEVICE. THE VENTILATOR WAS SET TO DELIVER A VOLUME OF 420, BUT ONLY 160 WAS ACTUALLY DELIVERED. THE PATIENT EXPERIENCED INITIAL INSTABILITY AND A SLIGHT WORSENING OF DESATURATION, WHICH WAS QUICKLY CORRECTED. TWO NURSES AND A PHYSIOTHERAPIST ATTEMPTED TO TIGHTEN THE SYSTEM AND REINFORCE THE TUBING, BUT DUE TO THE PATIENT'S INSTABILITY, THE SYSTEM WAS REPLACED WITH A TRACHEOSTOMY. THE SYSTEM WAS THEN REPLACED WITH A STANDARD CATHETER MOUNT PRODUCT, WHICH RESTORED NORMAL VENTILATION VOLUMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378173 DAR CATHETERS, SUCTION, TRACHEOBRONCHIAL BSY COVIDIEN 444SP02014 10884521822894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| R