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

Model Number	02-01846
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
This was previously reported under report number 2133409-2023-00034 and therefore is a duplicate mdr.

• 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: 17270110
• Report Number: 2133409-2023-00035
• Device Sequence Number: 18158012
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: +B146C6E10
• 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): 10/03/2024

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
• Date Returned to Manufacturer: 06/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 05/08/2024; Not provided
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 05/09/2024; 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male