BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIRCUIT, ADULT SINGLE-LIMB, HEATED

    MDR report key: 7108072 · Received December 12, 2017

    Report

    Report Number
    8030673-2017-00393
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    November 28, 2017
    Report Date
    March 27, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    OGL
    PMA / PMN Number
    ENFORCEMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOUR OPENED SAMPLES OF PART NUMBER AH 202 WERE RECEIVED AND A FAILURE INVESTIGATION WAS PERFORMED. THE TEMP PORTS OF THE COMPONENTS PART NUMBER 65-10139 WERE INSPECTED PER DRAWING 65-10139 AND WERE FOUND TO BE WITHIN SPECIFICATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED SO NO ROOT CAUSE COULD BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN A SUPPLEMENTAL REPORT WILL BE FILED. VYAIRE WILL CONTINUE TO TRACK AND TREND ANY RELATED ISSUES.

    Additional Manufacturer Narrative · 1

    INITIAL EMDR SUBMISSION: SAMPLE IS AVAILABLE, UPS SHIPPING LABELS PROVIDED TO CUSTOMER TO HAVE THE SAMPLE RETURNED. CURRENTLY AWAITING FOR THE SAMPLE. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP SUBMISSION WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT THE TEMPERATURE PROBE BECOMES DISLODGED FROM THE CIRCUIT AT THE HUMIDIFICATION CHAMBER WHEN USING WITH HIGH FLOW NASAL CANNULA. TODAY OUR DAY SHIFT SUPERVISOR REPORTED TO ME THAT WE HAVE HAD SEVERAL RAPID RESPONSES CALLED FOR HYPOXIA DUE TO THE TEMPERATURE PROBE BEING DISLODGED DOWN AND THE HEATER POT. OUR PREVIOUS CIRCUIT HAD A CLIP TO KEEP THIS IN PLACE, CAN THE MANUFACTURER CORRECT THIS WITH. ON 12/4/2017-ADDITIONAL INFORMATION: PRODUCT SAMPLE IS AVAILABLE. CLINICIAN WAS MADE AWARE OF THE ISSUE BECAUSE SATURATIONS DROPPED. NO MEDICAL INTERVENTION REQUIRED OTHER THAN CORRECTING THE ISSUE. DETAILS OF THE "RAPID RESPONSES" DESCRIBED BY CUSTOMER AS: "PATIENTS OXYGEN SATURATIONS DROPPED, NURSING COULD NOT FIND THE ISSUE AND RAPID RESPONSE CALLED". ON 08DEC2017-ADDITIONAL INFORMATION FROM CUSTOMER: YES THIS PRODUCT HAS NOT CHANGED SINCE WE BEGAN USING THEM, CLINICIANS WE AWARE WHEN THE PATIENTS PULSE OXIMETER ALARM WENT OFF, A RRT WAS CALLED BUT DEVICES WERE CORRECTED, PREVIOUS CIRCUIT HAD A CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886997 CIRCUIT, ADULT SINGLE-LIMB, HEATED OXYGEN ADMINISTRATION KIT OGL VYAIRE MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R