MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC EPATCH 2.5, BTH; EPATCH SENSOR - 2.5

Model Number	02-02045
Medical Device Problem Codes	Failure to Charge (1085); 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 epatch sensor - 2.5 was overheating and not charging.The sensor was returned for investigation.The sensor was inspected for general physical integrity and found in good condition.Engineering was able to replicate the allegations of an overheat during charging, no lights while charging, and the device being unable to charge.Sensor passed visual inspection but failed functional testing.Additional testing is pending.
Event or Problem Description
It was reported that the epatch sensor - 2.5 was getting really hot in the charger and that the sensor would not charge or upload data.There was no injury reported.No additional information was provided.

• Brand Name: EPATCH 2.5, BTH
• Common Device Name: EPATCH SENSOR - 2.5
• 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: 22774112
• Report Number: 2133409-2025-00072
• Device Sequence Number: 21167543
• Product Code: DSH
• UDI-Device Identifier: B146EP2510
• UDI-Public: +B146EP2510/
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K171410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2025

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: 02-02045
• Device Catalogue Number: 02-02045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 78 YR
• Patient Sex: Female