MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT C6S, 3.0

Device Problems Overheating of Device (1437); Smoking (1585); Temperature Problem (3022); Excessive Heating (4030)

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

Event Date 04/14/2023

Event Type  malfunction  

Event Description

Patient mother reported the power adapter cable for the monitor was smoking while plugged in car port and cable melted, charging usb cord was the issue.Replacement was ordered for patient.The charging cable was not working as expected.Device was not damaged while being used.Patient mother elected to break in service (bis).Patient was in school, mom was charging sensor at home and monitor in the car.Patient did not have device on at time of incident.There was no report of death or serious injury or harm to patient, operator, or bystander.Additional information was received from biotel support from patient mother on (b)(6)2023: patient mother reported the power adaptor cable for the monitor was smoking while plugged in her car charge port, cable melted, no obvious damage to the monitor.Battery depleted.

Manufacturer Narrative

Engineering evaluation was unable to be performed as the electrode/device was not returned.Follow up report will be sent upon investigation of returned part.

Manufacturer Narrative

It was reported that the power adapter cable for the monitor was smoking while plugged in car port and cable melted.A replacement device was sent to the patient.The device was returned for investigation.Engineering evaluation was unable to replicate the reported complaint of a power adaptor cable melting as there were no issues with charging the monitor.No charging cable was returned for root cause investigation nor was any objective evidence of a melted power cord provided.The most likely root cause of the reported event is the usb-c charging cord.

• Brand Name: UNIT C6S, 3.0
• Type of Device: UNIT C6S, 3.0
• 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
• MDR Report Key: 17105428
• MDR Text Key: 316968814
• Report Number: 2133409-2023-00028
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K171410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1