BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT

    MDR report key: 6921454 · Received October 6, 2017

    Report

    Report Number
    8030673-2017-00371
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    September 5, 2017
    Report Date
    February 21, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    OGL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RECEIVED AND WAS LOST IN TRANSIT. UNFORTUNATELY THE REPRESENTATIVE SAMPLES WERE NOT AVAILABLE FOR FURTHER EVALUATION SO THE FAILURE AND ROOT CAUSE COULD NOT BE CONFIRMED. IT HAS BEEN IDENTIFIED THAT A DEFECTIVE CRIMPING IN THE HEATER WIRE CAN POTENTIALLY CAUSE A BAD ELECTRICAL CONNECTION OF HEATING WIRE TO THE POWER SUPPLY AND THEREFORE GENERATE RAIN OUT IN THE CIRCUIT. DUE TO THIS POTENTIAL FAILURE A CAPA HAS BEEN INITIATED WITH THE FOLLOWING CONTAINMENT ACTIONS HAVE BEEN PERFORMED. VYAIRE IS DOING INSPECTION FOR 200% FOR WIRE RESISTANCE TO ENSURE CIRCUITS ARE FUNCTIONAL. INSPECTION FOR CORRECT WIRE RETAINER POSITION IS ALSO BEING PERFORMED. THE FOLLOWING PREVENTIVE ACTIONS ARE BEING IMPLEMENTED VYAIRE IS QUALIFYING CRIMP QUALITY MONITORS ON THE CRIMPER MACHINES, AND PERSONNEL ARE BEING RETRAINED ON THE ASSEMBLY PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). VYAIRE HAS RECEIVED A REPRESENTATIVE SAMPLE FROM THE SAME LOT NUMBER FOR FURTHER EVALUATION. VYAIRE IS CURRENTLY PERFORMING AN INVESTIGATION INTO THE REPORTED ISSUE. A FOLLOW UP MDR WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "TONS OF RAIN-OUT OBSERVED WITH HEATED SYSTEM. WHEN EXTUBATING THE PATIENT THE VENT TUBING BECAME DISLODGED AND THE WATER SPRAYED INTO MY FACE". RESPIRATORY THERAPIST WENT TO THE ER FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702263 CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT OXYGEN ADMINISTRATION KIT OGL VYAIRE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other