BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYMASK O2 KID

    MDR report key: 8617627 · Received May 16, 2019

    Report

    Report Number
    8022032-2019-00002
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 21, 2019
    Report Date
    May 16, 2019
    Manufacturer
    SOUTHMEDIC INC.
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS FORWARDED BY SOUTHMEDIC'S US DISTRIBUTION CENTER WITH NO CONTACT INFORMATION OF THE REPORTER PROVIDED; THEREFORE, SOUTHMEDIC IS UNABLE TO FOLLOW-UP WITH THE REPORTER FOR MORE INFORMATION. THUS, NO SAMPLES CAN BE REQUESTED FOR INVESTIGATION. THE LOT NUMBER PROVIDED IN THE MEDWATCH REPORT (MW5086084) DOES NOT MATCH WITH THE LOT NUMBER FORMAT THAT SOUTHMEDIC USES ON THE DEVICE LABELING. AS A RESULT, AN INVESTIGATION CANNOT BE CONDUCTED WITH RESPECT TO THE BATCH RECORD OF THE DEVICE. SEE [MEDWATCH MW5086084].

    Description of Event or Problem · 1

    PEDIATRIC OXYMASK WAS NOTED TO BE VERY LOUD WITH OXYGEN ADMINISTRATION AND THE PATIENT REQUIRED INCREASED OXYGEN. UPON EXAMINATION OF THE OXYMASK, A KINK IN THE TUBING WAS NOTED AT THE BASE OF THE MASK THAT TWISTED AND BLOCKED THE OXYGEN ADMINISTRATION TO THE PATIENT. A DIFFERENT MASK WAS PLACED ON THE PATIENT AND THE PROBLEM RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407944 OXYMASK O2 KID OXYGEN MASK BYG SOUTHMEDIC INC. OK-1125-8 LO1936F

    Patients

    Seq Age Sex Outcome Treatment
    1