MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC MCOT MOBILE CARDIAC OUTPATIENT TELEMETRY; CHARGE CORD, RED FOR A10E PHONE

Model Number 700-0770-01

Device Problems Melted (1385); Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

It was reported that the the charger for the c6 monitor melted while the monitor was charging.The device was returned for investigation.We are continuing to monitor the reported issue.The root cause is most probable to be the charging cord.

Event Description

It was reported that c6 monitor charger melted while the monitor was charging.There were no injuries reported.

Manufacturer Narrative

It was reported that the patient was experiencing peeling skin while wearing the electrodes.The electrodes did not return for investigation.Engineering evaluation was unable to be performed as the electrode/device was not returned.Allegation is confirmed through the need for a prescription and is most probable to be a bio-incompatibility issue with the electrode adhesive.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: MCOT MOBILE CARDIAC OUTPATIENT TELEMETRY
• Type of Device: CHARGE CORD, RED FOR A10E PHONE
• 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: 17451388
• MDR Text Key: 320347548
• Report Number: 2133409-2023-00044
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 700-0770-01
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/27/2023
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male