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

Model Number 02-01804

Device Problems Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198); Temperature Problem (3022); Excessive Heating (4030)

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

Event Date 10/29/2022

Event Type  malfunction  

Manufacturer Narrative

Device was inspected for general physical integrity and the charging port was inspected for evidence of damage.Damage to the charging port appeared to be external.Device started charge at 11:22am at 1458.3ma, device was charged fully at 1:18pm at 352.0ma, max temperature at 85.5f, normal.Total device charging time: 116 minutes.Device charged fully; device showed no signs of defect that could have contributed to overheat during charging.The temperature test was not performed as the overheat event happened during charging.The charging cord that was being used at the time of the event was not returned.Although it is more probable that the allegedly melted cord was damaged and experienced a fault in which allowed excess current to flow, resulting in an overheat.Conclusion: engineering evaluation was unable to confirm overheat event.It was observed that the device had a slightly melted screen near the charging port and the charging port was burned/melted patient was sent a replacement.

Event Description

Customer alleged that the monitor was not charging.Customer went to check on the phone and could smell burning.The phone was very hot to the touch.No issues with the cord were noted according to the customer.The customer was not harmed.

• Brand Name: UNIT, C6M, A10E
• 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: 15992611
• MDR Text Key: 305580361
• Report Number: 2133409-2022-00017
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: B146C6M70
• 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,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 02-01804
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/15/2022
• 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