MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT, C6M, A10E; 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	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer alleged that they received a melted cord but continued to use it and it smelled like it was burning when she plugged it in.Patient was worried that the monitor was damaged.
Additional Manufacturer Narrative
Engineering evaluation was completed results are as follows: device was inspected for general physical integrity and the charging port was inspected for evidence of damage.No problems found.Device started charge at 11:22am at 1442.2ma, device was charged fully at 12:34pm at 356.4ma, max temperature at 82.5f, normal.Total device charging time: 72 minutes.Device charged fully; device showed no signs of defect that could have contributed to overheat during charging see attachment 1 for results.The temperature test was not performed as the overheat event happened during charging.Device was production tested; no problems found.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 replicate overheat event.No problems found.Patient was sent a new monitor.

• Brand Name: UNIT, C6M, A10E
• 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: 15992427
• Report Number: 2133409-2022-00016
• Device Sequence Number: 17694382
• Product Code: DSI
• UDI-Device Identifier: B146C6M70
• UDI-Public: B146C6M70
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 02-01804
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 12/15/2022
• 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