MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 SENSOR 3.0; MCOT SENSOR - 3.0

Model Number	02-01846
Medical Device Problem Codes	Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025 that the patient began service.On (b)(6) 2025, the patient had an episode at school around 10am where emergency services were called.Upon further review of fetched data determined a sudden onset of svt on 21 january 2025 which was sustained for approximately 30 minutes.It was noted that artifact was present.It is unclear why the sustained tachyarrhythmia did not automatically trigger a severe tachycardia event.Based on the available information, there was a failure to auto-trigger a severe tachycardia event.
Additional Manufacturer Narrative
It was reported that the patient had an episode while at school and there was a failure to auto-trigger a severe tachycardia.The device was returned for investigation.The sensor was connected to a testing fixture and the log were downloaded and inspected for any errors during the monitoring period.No issues were identified.Engineering evaluation determined that there was no deficiency in either the device or monitoring service.An earlier review from engineering confirmed that the mcot system was functioning properly at the time of the allegation.Additional functional testing verified the sensor is in proper functioning order.The complaint is therefore unconfirmed.A clinical review was performed and the events transmitted on the date of the reported event were reviewed by the medical office.A review of fetched data determined a sudden onset of svt on (b)(6) 2025 1259 est which was sustained for approximately 30 minutes.Artifact was present.It is unclear from the clinical review why the sustained tachyarrhythmia did not automatically trigger a severe tachycardia event.Based on the available information, there was a failure to auto-trigger a severe tachycardia event.The cause cannot be determined by clinical review.

• Brand Name: C6 SENSOR 3.0
• Common Device Name: MCOT SENSOR - 3.0
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 21470925
• Report Number: 2133409-2025-00008
• Device Sequence Number: 3567741
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• Combination Product (Y/N): N
• PMA/510(K) Number: K153473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01846
• Device Catalogue Number: 02-01846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR
• Patient Sex: Male