MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT C6S, 3.0, BTH

Model Number	02-01846
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient's wife returned the sensor to clinic after her husband wore it for a day.No injuries were reported but after assessing picture it noted that the sensor melted/burned.Additional information was requested but not received.
Additional Manufacturer Narrative
It was reported that the sensor was melted/burned.The sensor 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.

• Brand Name: UNIT C6S, 3.0, BTH
• Common Device Name: UNIT C6S, 3.0, BTH
• 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: 17269863
• Report Number: 2133409-2023-00034
• Device Sequence Number: 12233576
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10/$$+7SE23511729X
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/24/2024; Not provided
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 02/07/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male