BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT HEATED WIRE CIRCUIT

    MDR report key: 7761739 · Received August 8, 2018

    Report

    Report Number
    8030673-2018-00010
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Date of Event
    June 24, 2018
    Report Date
    August 15, 2018
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    OGL
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THE 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. THIS ISSUE WILL BE INTERNALLY INVESTIGATED WITHIN VYAIRE.

    Additional Manufacturer Narrative · 1

    OTHER-AT THIS TIME, THE SUSPECT COMPONENT IS NOT AVAILABLE FOR RETURN. DUE TO THE PART NOT BEING AVAILABLE TO BE RETURNED, NO FURTHER EVALUATION CAN BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    THE RESPIRATORY THERAPIST REPORTED: EXCESSIVE RAIN-OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604649 INFANT HEATED WIRE CIRCUIT OXYGEN ADMINISTRATION KIT OGL VYAIRE MEDICAL 0001119873

    Patients

    Seq Age Sex Outcome Treatment
    1 Other