MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC C6S MCOT UNIT

Lot Number U210446

Device Problems Fire (1245); Smoking (1585); Patient-Device Incompatibility (2682); Biocompatibility (2886); Temperature Problem (3022); Excessive Heating (4030)

Patient Problems Erythema (1840); Full thickness (Third Degree) Burn (2696); Blister (4537)

Event Date 02/11/2022

Event Type  Injury  

Manufacturer Narrative

Patient followed skin preparation regiment and instructions.Patient was offered lead wire adapter for device, but declined and no longer wants to wear the device.Device not available for evaluation at this time.

Event Description

Biotel heart distributor notified braemar that a patient alleged that the sensor caught fire and was smoking.Patient alleged that sustained three scars and third degree burns.Patient claims to have sought medical attention at the urgent care and was prescribed an antibiotic burn cream to apply to the affected area.

Manufacturer Narrative

Engineering evaluation is not able to be performed as the sensor is with a new patient.The sensor as of 23nov2022 has been functioning as intended and without further allegation.Due to the continued function of the sensor, it did not likely experience an overheat event.The images provided exhibit skin irritations at the site of electrode placement.It is most probable cause of the skin issue is that the patient experienced a bio-incompatibility event to the electrode that was perceived as a thermal event.Electrodes are single use devices.In this case the electrode was not returned for evaluation.Allegations of third degree burns, smoke, and fire could not be confirmed.The electrodes were not available for return by patient as these are single use devices.The electrode was the biotel universal patch that was worn by the patient at the time of the event.Marsi, skin burn, and associated symptoms may inherently occur under the course of ecg monitoring.No single factor or combination of factors can be attributable to electrode skin irritation and associated symptoms.The product labeling advises patients of alternate options and other steps to take if skin irritation develops, including healthcare professional contact as needed.

• Brand Name: C6S MCOT UNIT
• Type of Device: C6S MCOT UNIT
• 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: 15397906
• MDR Text Key: 299657281
• Report Number: 2133409-2022-00006
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: U210446
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male