MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT, C6M, A10E U

Model Number	02-01804
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198); Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Biotel heart customer support notified braemar that a patient had an event monitor placed earlier this month, which encountered an electrical issue that did not result in patient or family harm.The family noticed a burning smell in the middle of the night and identified that it was the event monitor cell phone which was charging.They were able to unplug the device before further damage occurred.
Additional Manufacturer Narrative
Device is being returned for evaluation by manufacturing/supplier.A follow up report will be sent when investigation has been completed.
Additional Manufacturer Narrative
Engineering evaluation was completed.Device was inspected for general physical integrity.The charging cord was melted and stuck into the monitor and there was melting along near the charging port on the monitor.The charging cable was removed from the monitor and inspected.The circuits leading up to the usb-c connection components were melted.The connection component was mostly ok with melted plastic still covering the metal connector.Monitor was inspected; the outside case was melted and the contacts within the port were melted.Monitors circuit board was inspected and the circuit board showed no signs of damage.Conclusion: engineering evaluation was able to confirm the device melt, although the source of the melt was most probable to be the charging cord.There were minimal signs of damage to the monitor itself suggesting that it was functioning as intended.

• Brand Name: UNIT, C6M, A10E U
• Common Device Name: UNIT, C6M, A10E U
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan MN 56121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121 ; 6124263781
• MDR Report Key: 15860836
• Report Number: 2133409-2022-00015
• Device Sequence Number: 6909461
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: B146C6M70
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 02-01804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 11/24/2022
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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