BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTER NEO-VERSO INFANT/NEO Y W/DIR CON

    MDR report key: 6175564 · Received December 15, 2016

    Report

    Report Number
    3010838917-2016-00019
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 1, 2016
    Report Date
    April 24, 2017
    Manufacturer
    AOK TOOLING LIMITED
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) -EXP - THE COMPLAINT SAMPLE WAS PROVIDED TO THE MANUFACTURING FACILITY AND AN INVESTIGATION WAS COMPLETED. THROUGH THE STUDY OF THE APPEARANCE AND MEASUREMENTS OF THE DIMENSIONS OF THE RETURNED COMPLAINT PRODUCT, THE PRODUCT WAS FOUND TO MEET ALL DIMENSIONAL SPECIFICATIONS. THROUGH THIS INVESTIGATION, NO ISSUES WERE FOUND WITH THE COMPLAINT SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THIS LOT. THERE WERE NO ISSUES IDENTIFIED WITH THE MATERIAL OR MANUFACTURING PROCESS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4) - THE COMPLAINT SAMPLE HAS NOT BEEN PROVIDED FOR EVALUATION AT THIS TIME. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, A FOLLOW-UP SUBMISSION WILL BE COMPLETED. (B)(4).

    Description of Event or Problem · 1

    UNDER INVESTIGATION COMPATIBILITY PROBLEM WITH DRAEGER BABYLOG NEONATAL Y-PIECE FLOW SENSOR. ACCORDING TO THE DISTRIBUTOR, A CUSTOMER (SALERNO) HAS STARTED TO USE NEO-VERSO WITH DRAEGER BABYLOG NEONATAL Y-PIECE FLOW SENSOR; THEY USE VENTILATOR WITH F&P HUMIDIFIER. AFTER SOME MINUTES OF USE, NEO-VERSO SLIPS OUT AND THE PATIENT STOPS TO BE VENTILATED WITH HIGH RISK TO DIE. THEY TESTED NEO-VERSO WITH MORE THAN ONE BABYLOG FLOW SENSOR (ALL NEW) BUT THE ISSUE STAYS. BEFORE USING VERSO, THE CUSTOMER USED KIMBERLY CLARKS CLOSED SUCTION SYSTEM WITHOUT ANY PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826768 ADAPTER NEO-VERSO INFANT/NEO Y W/DIR CON CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI AOK TOOLING LIMITED 201004130002

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R