BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIT,C6S 3.0,BTH

    MDR report key: 17270110 · Received July 6, 2023

    Report

    Report Number
    2133409-2023-00035
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Report Date
    October 3, 2024
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146C6E10
    PMA / PMN Number
    K081444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS WAS PREVIOUSLY REPORTED UNDER REPORT NUMBER 2133409-2023-00034 AND THEREFORE IS A DUPLICATE MDR.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SENSOR MELTED. THE DEVICE WAS RETURNED FOR INVESTIGATION. ENGINEERING EVALUATION WAS ABLE TO CONFIRM THE MELTED DEVICE. THE ROOT CAUSE WAS DAMAGE TO THE BATTERY. MOST PROBABLE TO BE EITHER A POOR SEAL OF THE BATTERY LEADING TO LEAKAGE OF THE BATTERY AND CAUSING A FAULT WHICH OVER HEATED THE BATTERY OR CONTAMINATION DURING MANUFACTURING WHICH CAUSED EXCESS GAS RELEASE ALSO DAMAGING THE BATTERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SENSOR MELTED. THERE IS NO REPORTS THAT THE PATIENT WAS HARMED OR SOUGHT MEDICAL ATTENTION. NO ADDITIONAL INFORMATION IS AVALIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787407 UNIT,C6S 3.0,BTH UNIT,C6S 3.0,BTH DSI BRAEMAR MANUFACTURING, LLC 02-01846 B146C6E10

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male