MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC MCOT C6

Device Problems Electrical /Electronic Property Problem (1198); Unintended Electrical Shock (4018)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

Product has been requested for return.Further information will be provided when investigation is complete.

Event Description

Patient reported that the charger adaptor component broke and the plug came out and she was shocked.There was no injury, but she knew she had been shocked.A replacement was ordered for the patient to continue enrollment.

Manufacturer Narrative

It was reported that the charge adapter broke when attempting to remove the plug from outlet.While attempting to remove the plug the patient was shocked.The charger did not return for investigation.Failure description matching an existing failure mode in which the contacts of the power adaptor housing remain in the 120v socket on attempt to remove from the wall.Philip's am&d is further investigation this issue.

• Brand Name: MCOT C6
• Type of Device: MCOT 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 dr; suite 150; eagan
• MDR Report Key: 16935282
• MDR Text Key: 315301891
• Report Number: 2133409-2023-00020
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/15/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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