MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT, J3 BTP-1000M, C6

Model Number	100-0046-02
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 monitor was overheating while charging, no patient harm was reported.The device returned and an investigation was performed.Engineering evaluation was able to confirm overheat.Root cause is most probable to be a fault from the charging cord.
Event or Problem Description
The patient reported an overheat while charging the monitor.The patient was not injured and therefore did not seek medical attention.It is unkown if the charging cord was warm as the patient did not check/recall.

• Brand Name: UNIT, J3 BTP-1000M, C6
• Common Device Name: UNIT, J3 BTP-1000M, C6
• 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: 17268702
• Report Number: 2133409-2023-00033
• Device Sequence Number: 6059084
• Product Code: DSI
• UDI-Device Identifier: B146C6M40
• UDI-Public: B146C6M40
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2023

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: 100-0046-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 07/06/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Unknown