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

Model Number 02-01846

Device Problem Solder Joint Fracture (2324)

Patient Problem Electric Shock (2554)

Event Date 11/26/2023

Event Type  Injury  

Event Description

It was reported that on 26 november 2023 the patient was charging the c6 sensor and she went to unplug it and the charger came apart and the prongs were stuck in the outlet.The patient was shocked from the end of the charging cord.Th electrical power was turned off to allow the prongs to be removed from the outlet.The patient did not seek medical treatment for the shock.A replacement charger was ordered and sent to the patient.

Manufacturer Narrative

It was reported that the patient was plugging the mcot device and when plugging the duel charging plug into the wall outlet the chager fell apart leaving the prongs in the outlet and the patient was shocked.The device was not returned.Engineering evaluation was unable to be performed.Although sensor was returned on se23645446, the charging block was not received back.The sensor is not implicated in the allegation as the patient states that the charging block fell apart in the outlet.Pictures were also not provided so engineering is unable to confirm the allegation.Although the component was not received and images were not provided, the problem description of this failure aligns with an known issue that is further being investigated by philips am&d.

• Brand Name: C6 MCOT PPM
• Type of Device: C6 SENSOR
• 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
• Manufacturer Contact: beverly okoh ; 1285 corporate center drive; suite 150; eagan, MN 55121
• MDR Report Key: 18345178
• MDR Text Key: 330794399
• Report Number: 2133409-2023-00078
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: B146C6E10
• UDI-Public: B146C6E10
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• 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?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUAL USB CHARGING PLUG, 700-0718-01
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female