BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C6 WITH UNIVERSAL ELECTRODE PATCH

    MDR report key: 15736395 · Received November 4, 2022

    Report

    Report Number
    2133409-2022-00012
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    September 23, 2022
    Report Date
    November 4, 2022
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    PMA / PMN Number
    K171410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SENSOR (B)(4) WAS NOT RETURNED FOR ENGINEERING EVALUATION. SENSOR DOES NOT MAKE CONTINUOUS CONTACT WITH THE PATIENT SKIN DURING USE AND IS NOT LIKELY TO CAUSE A SKIN IRRITATION. FOR SHOCK, SENSOR COMPLIES WITH IEC 60601-2-47 FOR MEDICAL DEVICE SAFETY. ADDITIONALLY ACCORDING TO IEC 60601 THE DEVICE IS CONSIDERED A LOW VOLTAGE MEDICAL DEVICE POWERED AT DC 3.7VOLTS (DEVICE CRITERIA FOR LOW VOLTAGE >7.2V). CONSIDERING THE DEVICES LOW VOLTAGE, THE DEVICE IS UNLIKELY TO BE THE SOURCE OF A PERCEPTIBLE SHOCK. ELECTRODE P200999 MAKES CONTINUOUS CONTACT WITH PATIENT SKIN AND THE PATIENT LIKELY HAD AN ADVERSE REACTION TO THE ELECTRODE ADHESIVE. 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 PATIENT SKIN IRRITATION HAS BEEN RESOLVED AND IS CURRENTLY USING A REPLACEMENT DEVICE.

    Description of Event or Problem · 0

    BIOTEL HEART CUSTOMER SUPPORT NOTIFIED BRAEMAR THAT THE PATIENT CALLED WITH SKIN IRRITATION AND WHAT FELT LIKE BEING SHOCKED TWO TIMES FROM THE SENSOR. PATIENT CONSULTED A CLINICIAN AND WAS PRESCRIBED CORTISONE CREAM FOR MEDICAL TREATMENT. PATIENT SKIN IRRITATION HAS BEEN RESOLVED AND IS CURRENTLY USING A REPLACEMENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229132 C6 WITH UNIVERSAL ELECTRODE PATCH C6 WITH E-PATCH V 2.0 UNIVERSAL PATCH DSI BRAEMAR MANUFACTURING, LLC P200999

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other