BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCUIT, NEONATAL 60" 10MM HOSE, .5L, LF

    MDR report key: 7319895 · Received March 7, 2018

    Report

    Report Number
    8030673-2018-00415
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    February 22, 2018
    Report Date
    April 12, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNFORTUNATELY THE ACTUAL CIRCUIT USED DURING THE CASE WAS DISPOSED OF. THE ONLY THING THAT WAS SAVED FROM THE CASE WAS THE SMALL PIECE OF PLASTIC THAT BLOCKED THE FILTER. ATTACHED TO COMPLAINT ARE PHOTOS OF THE PLASTIC PIECE. IF A SAMPLE OR ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP EMDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE VYAIRE FAILURE ANALYSIS LAB RECEIVED THE PHOTO OF THE PLASTIC THAT WAS LODGED BETWEEN THE FACE MASK AND THE FILTER. THE PIECE OF PLASTIC IS NOT PART OF THE CIRCUIT THEREFORE, THE REPORTED ISSUE IS NOT ABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED "DURING RESUSCITATION OF PATIENT, THEY WENT TO USE THE ANESTHESIA CIRCUIT. DURING USE, THEY NOTICED THAT THE PATIENT WAS STRUGGLING FOR AIR SO THEY QUICKLY EVALUATED AND FOUND THAT THERE WAS A PIECE OF PLASTIC LODGED BETWEEN THE FACE MASK AND FILTER. THEY QUICKLY REMOVED THE PLASTIC FILM AND CONTINUED TO RESUSCITATE THE PATIENT". "THE PATIENT RECOVERED AND THERE WAS NO HARM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163705 CIRCUIT, NEONATAL 60" 10MM HOSE, .5L, LF CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI VYAIRE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention