MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT, EPATCH 2.0,BTI

Model Number	02-01650
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was hot to the touch and the battery was swelling/budging with visible cracks.There was no report of death or serious injury, or impact to patient.
Additional Manufacturer Narrative
Engineering evaluation was completed on 22may2023.Device was inspected for general physical integrity, the device case was cracked.Device started charge at 9:10am at 65.5ma, slow blinking white led, at 79.4f.Device charging was stopped at 9:40am at 449.3ma at 107.4f as this exceeds the limit for device heating.See attachment 1 for results.Device was opened to visually inspect for damage and corrosion that may have caused of contributed to allegation.The printed circuit board showed no signs of damage.The battery was swollen and the covering was wrinkled.Conclusion: engineering evaluation was able to confirm charging overheat/bulging issue.Device exceeded normal operating temperatures.Root cause is likely due to the swelling of the battery.Summary: it was reported that the device was hot to the touch and the battery was swelling/budging with visible cracks.The device returned for investigation and engineering evaluation was able to confirm charging overheat/bulging issue.Device exceeded normal operating temperature.Root cause is most probable to be due to the swelling of the battery.

• Brand Name: UNIT, EPATCH 2.0,BTI
• Common Device Name: UNIT, EPATCH 2.0,BTI
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan MN 55121
• MDR Report Key: 17043743
• Report Number: 2133409-2023-00025
• Device Sequence Number: 21028674
• Product Code: DSI
• UDI-Device Identifier: B146EP2020
• UDI-Public: B146EP2020
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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: 02-01650
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/01/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown