BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYMASK ADULT ETCO2

    MDR report key: 7663815 · Received July 5, 2018

    Report

    Report Number
    8022032-2018-00001
    Event Type
    Malfunction
    Date Received
    July 5, 2018
    Date of Event
    January 22, 2018
    Report Date
    February 13, 2018
    Manufacturer
    SOUTHMEDIC, INC.
    Product Code
    CCK
    PMA / PMN Number
    K014211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    [(B)(4)].

    Description of Event or Problem · 1

    THE DIFFUSER PIN CAME OFF OF THE OM-2125-8 OXYMASK AND INTO THE PATIENT'S THROAT. THE MASK WAS USED DURING TEE PROCEDURE AND IT HAD BEEN POST PROCEDURE WHEN THE PART WAS DISCOVERED IN THE PATIENT'S THROAT. THE PATIENT COUGHED UP THE DIFFUSER PIN AND THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507476 OXYMASK ADULT ETCO2 OXYMASK CCK SOUTHMEDIC, INC. OM-2125-8 W37743

    Patients

    Seq Age Sex Outcome Treatment
    1