MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6 MCOT PPM

Model Number 02-01606

Device Problem Unintended Electrical Shock (4018)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 02/09/2024

Event Type  Injury  

Event Description

It was reported on 10 february 2024, that on (b)(6) 2024 the patient went to the emergency room (er) because they felt electric shocks under their armpit and towards the left side of their chest.The patient stated it felt like a teaser shock.The er ran tests such as an ekg (electrocardiography) and lab work.Everything was normal.The hospital staff noted that it could have been the heart monitor that could have caused the issue.The patient removed the device and has not had any issues since removing the device.

Manufacturer Narrative

It was reported that the patient expereinced a electrical shock under their armpit.The device was returned for investigation.Engineering evaluation could not replicate the reported event of the patient feeling a shock.The sensor passed all testing and found to be working according to specifications.

• Brand Name: C6 MCOT PPM
• Type of Device: C6 MCOT PPM
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN 55121
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 18832869
• MDR Text Key: 336853071
• Report Number: 2133409-2024-00015
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081444
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02-01606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male