MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT; UNIT, C6M, A10E , U

Device Problems Thermal Decomposition of Device (1071); Failure to Charge (1085); Electrical /Electronic Property Problem (1198); Charging Problem (2892); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

Battery was reported as unable to power on.Patient was instructed to remove the back case of the device and remove the orange ribbon from backing to remove the battery.Device is an a10e model from samsung and does not feature a removable back or battery.The backing should only be removed by persons trained to disassemble device and have appropriate tools.During disassembly the battery experienced a thermal runaway event.Initial inspection of the back casing shows that the liner was damaged during the removal and the slot for the sim card is damaged.In order to remove the back case the sim card holder must first be removed; this was not completed.This indicates that the customer was not using correct tools or methodology to remove back casing and had the potential to damage the battery.Inspection of the flex wire circuitry referred to as "orange ribbon" in the complaint shows evidence of continued prying without proper removal of the covering to the printed circuit board to disconnect flex wire.This is a second potential source of damage to the battery that could have caused a thermal event.Review of the flex wire connections shows that the thermal event did not originate from the prying around the flex wire connections.Images show more severe damage than the rest of the battery and shows that the battery is not seated properly in the device.The incorrect seating and severe damage indicates that the source of the thermal event originated here and that it is likely that the patient caused damage to the battery while attempting to pry it out with a tool.Conclusion: the source of the battery thermal runaway event is most probable to be due to damage caused by incorrect advisement from patient services and improper use of the device by the patient.The battery was likely damage by a sharp or metal tool that created a fault and subsequently a battery thermal runaway event.

Event Description

Battery was reported as unable to power on.Patient was instructed to remove the back case of the device and remove the orange ribbon from backing to remove the battery.Device is an a10e model from samsung and does not feature a removable back or battery.The backing should only be removed by persons trained to disassemble device and have appropriate tools.During disassembly the battery experienced a thermal runaway event.

• Brand Name: C6 MCOT
• Type of Device: 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: 16186423
• MDR Text Key: 307508799
• Report Number: 2133409-2023-00002
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K171410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2022
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1