BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 25094981 · Received May 6, 2026

    Report

    Report Number
    3010838917-2026-00003
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 6, 2026
    Manufacturer
    AIRLIFE FINLAND OY
    Product Code
    BTL
    UDI-DI
    10190752135697
    PMA / PMN Number
    K093913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANNEX G - 4756 - APPROPRIATE COMPONENT TERM/CODE NOT AVAILABLE - T-PIECE NEONATAL PATIENT CIRCUIT KIT. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. THE CUSTOMER REPORTED THAT THEY WERE ABLE TO SOURCE THREE TOTAL LOTS FOR THE AFFECTED PRODUCT. THE ADDITIONAL TWO LOT NUMBERS IDENTIFIED ARE 250761365 AND 251291365. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 06 MAY 2026 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE REPRESENTS ALL OF THE INFORMATION KNOWN AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT-14371. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT, AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT WAS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE T PIECE NEONATAL PATIENT CIRCUIT KITS WERE NOT REGISTERING A PEEP PRESSURE. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295638 N/A T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE BTL AIRLIFE FINLAND OY M1091365VS WO40127 10190752135697

    Patients

    Seq Age Sex Outcome Treatment
    1