BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C6 SENSOR 3.0

    MDR report key: 20049040 · Received August 23, 2024

    Report

    Report Number
    2133409-2024-00052
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 26, 2024
    Report Date
    December 23, 2024
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    PMA / PMN Number
    K081444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE MCOT SENSOR - 3.0 BURNED THE PATIENT. THE MCOT SENSOR - 3.0 WAS RETURNED FOR DEVICE EVALUATION. SENSOR WAS INSPECTED FOR GENERAL INTEGRITY AND ONLY MINOR WEAR AND TEAR WAS IDENTIFIED. THE SENSOR PASSED VISUAL INSPECTION. GINEERING EVALUATION COULD NOT REPLICATE THE SENSOR OVERHEAT OR SHOCK AS THE SENSOR WAS WITHIN SPECIFICATIONS; HOWEVER, THE PATIENT HARM OF "MARK IN SHAPE OF SENSOR", WAS CONFIRMED. THE C6 SENSOR WAS WITHIN NORMAL OPERATING TEMPERATURE RANGES AND PASSED ALL FUNCTIONAL VERIFICATION TESTING. IMAGES PROVIDED BY THE PATIENT CONFIRM THE REPORTED ALLEGATION, WHICH IS MOST LIKELY ATTRIBUTED TO BIOCOMPATIBILITY WITH THE PATCH ELECTRODE. MARSI, SKIN BURN, AND ASSOCIATED SYMPTOMS MAY INHERENTLY OCCUR UNDER THE COURSE OF ECG MONITORING. NO SINGLE FACTOR OR COMBINATION OF FACTORS CAN BE ATTRIBUTABLE TO ELECTRODE SKIN IRRITATION AND ASSOCIATED SYMPTOMS. THE PRODUCT LABELING ADVISES PATIENTS OF ALTERNATE OPTIONS AND OTHER STEPS TO TAKE IF SKIN IRRITATION DEVELOPS, INCLUDING HEALTHCARE PROFESSIONAL CONTACT AS NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON 26 JULY 2024 THE PATIENT WAS BURNED BY THE C6 SENSOR WHILE THEY WERE SLEEPING. THE PATIENT REPORTED THAT THE SENSOR ELECTROCUTED AND "SEVERELY" BURNED THEM. THE PATIENT REPORTED THAT THERE WAS A BURN ON THEIR CHEST IN THE SHAPE OF THE SENSOR. THE PATIENT DETAILED THAT THE BURN WAS PAINFUL, VERY RED AND OPEN SORE AND RAW. DUE TO THE BURN THE PATIENT WENT TO THE URGENT CARE. IT IS UNCLEAR IF THEY BURN WAS TREATED WITH ANY MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742013 C6 SENSOR 3.0 MCOT SENSOR - 3.0 DSI BRAEMAR MANUFACTURING, LLC 02-01846

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention