BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS¿

    MDR report key: 16501431 · Received March 8, 2023

    Report

    Report Number
    16501431
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 9, 2023
    Report Date
    February 16, 2023
    Manufacturer
    VYAIRE MEDICAL, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VITAL SIGNS¿ PEDIATRIC ANETHESIA BREATHING CIRCUITS (LOT #0004223761 AND 0004223420) HAVE HOLES IN THE CIRCUIT CAUSING AN AIR LEAK. IT WAS IDENTIFIED THAT 2 OF THE PEDIATRIC CIRCUIT HAD HOLES IN THE CREASES OF THE CIRCUIT. OTHER CIRCUITS WITH THE SAME LOT NUMBER WERE EXAMINED FOR DEFECTS AND NO OTHERS WERE FOUND. THE PRODUCT WAS IN THE PROCESS OF BEING ATTACHED TO THE PATIENT WHEN THE DAMAGE WAS FOUND. IT WAS NOTICED WHEN THE TUBING WAS EXTENDED AND THE ANESTHESIA GAS BEGAN TO LEAK. A NEW CIRCUIT WAS OBTAINED AND USED IN PLACE OF THE FAULTY PRODUCT. WITH THESE LEAKS, THE HARM IS TO THE PATIENT AND THE CAREGIVERS IN THE OPERATING ROOM AS THE GAS IS RELEASED INTO THE SUITE. MANUFACTURER RESPONSE FOR CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE), VITAL SIGNS¿ (PER SITE REPORTER). VYAIRE MEDICAL, INC. HAS BEEN MADE AWARE, AND THEY ARE IN THE PROCESS OF INVESTIGATING. WE ARE WORKING TO SEND A SAMPLE OF THE DEFECTIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735428 VITAL SIGNS¿ CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI VYAIRE MEDICAL, INC. B1714XXX 0004223761

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown