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

Model Number 02-01846

Device Problem Sparking (2595)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 06/11/2023

Event Type  Injury  

Event Description

It was reported by patient and her daughter that the sensor was not charging.The daughter said her mother had been defibrillated and that sparks came out of the sensor.The patient was advised to remove the blue casing of the patch.The sensor was flashing red.A replacement sensor was ordered in case of it being damaged during the defibrillation.The patient will try to reconnect a few hours after the sensor is charged.

Manufacturer Narrative

It was reported when patient was being defiblilated sparks came out of the sensor.The sensor was returned for investigation.Engineering evaluation could not replicate the reported event of "the sensor was not charging and sparks coming out of the sensor." per the patient education guide (peg) it specifically states "remove braemar telemetry system patch and sensor before using an external defibrillator." any spark observed during defibrillation is most likely the result of the voltage discharged by the automated external defibrillator (aed) and not a product malfunction.Any issue with charging is also likely resulting from patient defibrillation.

• 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: 17882478
• MDR Text Key: 325060639
• Report Number: 2133409-2023-00063
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 02-01846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Initial Date Manufacturer Received: 09/05/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female