BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARVIEW NASAL MASK

    MDR report key: 15819741 · Received November 17, 2022

    Report

    Report Number
    2020813-2022-00007
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Report Date
    November 17, 2022
    Manufacturer
    ACCUTRON, INC.
    Product Code
    KHA
    UDI-DI
    00813830025965
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP WITH THE USER FACILITY, ACCUTRON LEARNED THAT MORE THAN ONE PATIENT HAD ADVERSE EVENTS FROM THE CLEARVIEW NASAL MASK. THE USER FACILITY DECLINED TO PROVIDE THE NUMBER OF PATIENTS OR DATES OF THE EVENTS. IT WAS REPORTED THAT EACH PATIENT RECOVERED ON THEIR OWN WITH NO MEDICAL TREATMENT BEING SOUGHT OR ADMINISTERED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    ACCUTRON HAS REQUESTED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT AND THE CURRENT PATIENT STATUS. TO DATE, WE HAVE NOT RECEIVED A RESPONSE WITH ADDITIONAL INFORMATION. THE USER FACILITY WAS PROVIDED WITH A COPY OF THE INSTRUCTIONS FOR USE FOR THE CLEARVIEW NASAL MASK AND CLEARVIEW SCAVENGING CIRCUIT AS REQUESTED. THE CLEARVIEW NASAL MASK INSTRUCTIONS FOR USE STATES, "WARNINGS: TO BE USED ONLY BY A PROFESSIONAL TRAINED IN THE USE OF NITROUS OXIDE, USING TITRATION METHOD. PATIENT SHOULD ALWAYS BE CLOSELY MONITORED DURING NITROUS OXIDE USE. IF PATIENT HAS AN ADVERSE REACTION, REDUCE OR STOP THE FLOW OF NITROUS OXIDE AS NEEDED." A FOLLOW-UP MDR WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A PATIENT EXPERIENCED ADVERSE EFFECTS AFTER USING A CLEARVIEW NASAL MASK DURING A DENTAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2705800 CLEARVIEW NASAL MASK MASK KHA ACCUTRON, INC. 33037-10 00813830025965

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown