BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT HEATED WIRE CIRCUIT

    MDR report key: 7748452 · Received August 3, 2018

    Report

    Report Number
    8030673-2018-00004
    Event Type
    Injury
    Date Received
    August 3, 2018
    Date of Event
    June 25, 2018
    Report Date
    August 22, 2018
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    OGL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BY OUR QUALITY TEAM. HOWEVER, THE QUALITY TEAM IDENTIFIED THAT A DEFECTIVE CRIMPING COULD CAUSE BAD ELECTRICAL CONNECTION OF HEATING WIRE TO THE POWER SUPPLY. THIS COULD GENERATE RAIN OUT IN THE CIRCUIT. IF SET UP TO CRIMPING EQUIPMENT IS NOT PROPERLY DONE, THE CRIMPING HEIGHT CAN BE OUT OF SPEC.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SAMPLE FOR INVESTIGATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE NURSE REPORTED EXCESSIVE WATER CONDENSATION WHILE USING THE INFANT HEATED WIRE CIRCUIT. THE NURSE OBSERVED EXCESSIVE CONDENSATION IN BOTH THE EXPIRATORY AND INSPIRATORY LIMBS AND THE BABY'S FACE IS CONSTANTLY WET REQUIRING MULTIPLE RE-TAPES. THE NURSE REPORTED THE CIRCUIT WAS CHANGED OUT AND NO PATIENT CONSEQUENCE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590971 INFANT HEATED WIRE CIRCUIT OXYGEN ADMINISTRATION KIT OGL VYAIRE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention