BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VYARIE MEDICAL

    MDR report key: 19326333 · Received May 15, 2024

    Report

    Report Number
    8030673-2024-01005
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    February 21, 2024
    Report Date
    May 2, 2024
    Manufacturer
    VYARIE MEDICAL
    Product Code
    BTT
    UDI-DI
    10190752144798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 02 MAY 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUNMED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUNMED HOLDINGS LLC. SUNMED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUNMED HOLDINGS LLC COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT SUNMED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 000611653 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. THE ACTUAL SAMPLE, FROM THE REPORTED EVENT WAS RETURNED AND EVALUATED, NO ISSUES WERE OBSERVED ON DEVICE. THE REPORTED FAILURE WAS NOT REPRODUCED IN THE LAB DURING SAMPLE EVALUATION; THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED AND NO CORRECTIVE/PREVENTATIVE ACTIONS WERE INITIATED. ALL INFORMATION REASONABLY KNOWN AS OF 17 MAY 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUNMED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUNMED HOLDINGS LLC. SUNMED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUNMED HOLDINGS LLC COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT SUNMED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE FIRST CONCENTRATOR SHUT DOWN AND THE CONCENTRATOR AND BOTTLE WERE REPLACED. THE "SECOND CONCENTRATOR SHUTDOWN. "THROUGH THE NIGHT ANOTHER CONCENTRATOR AND BOTTLE [WERE] REPLACED, IN THE MORNING, YET ANOTHER ONE." IT WAS ADDITIONALLY REPORTED, THE INCIDENT OCCURRED DURING SETUP AT THE PATIENT BEDSIDE AND THE PATIENT EXHIBITED DISTRESS AND AGITATION; HOWEVER, THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    IIT WAS REPORTED, THE FIRST CONCENTRATOR SHUT DOWN AND THE CONCENTRATOR AND BOTTLE WERE REPLACED. THE "SECOND CONCENTRATOR SHUTDOWN. "THROUGH THE NIGHT ANOTHER CONCENTRATOR AND BOTTLE [WERE] REPLACED, IN THE MORNING, YET ANOTHER ONE." IT WAS ADDITIONALLY REPORTED, THE INCIDENT OCCURRED DURING SETUP AT THE PATIENT BEDSIDE AND THE PATIENT EXHIBITED DISTRESS AND AGITATION; HOWEVER, THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453696 VYARIE MEDICAL NEBULIZER WITH AIR ENTRAINMENT BTT VYARIE MEDICAL 002002 000611653 10190752144798

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other