MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC UNIT,C6S 2.5,BTH; C6 MCOT

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

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

Event Date 04/13/2022

Event Type  malfunction  

Manufacturer Narrative

Evice was inspected for general physical integrity, device contacts were melted.Device was unable to undergo charging heat stress test as the case enclosing some contacts were melted upon arrival.The device was opened to inspect for damage that could have contributed to the device melt.The mezzanine board connecter was melted and the battery showed signs of leakage.Conclusion: engineering evaluation was able to confirm device melt.The root cause is most probable to be a battery leakage that cause a fault and a melt event.Summary: it was reported that the device was hot to the touch and the battery was swelling/budging with visible cracks.The device returned for investigation and engineering evaluation was able to confirm charging overheat/bulging issue.Device exceeded normal operating temperature.Root cause is most probable to be due to the swelling of the battery.

Event Description

It was reported to biotel heart distribution on (b)(6) 2022 the sensor is getting hot.On 24 february 2023 braemar complaint handling unit was notified of this complaint.Additional information was received from patient services on 21 april 2023 regarding patient: the gold strip of the bottom of the sensor is melted and a replacement was ordered and sent to patient.The was no mention of injury or any other impact other than what was observed.

Manufacturer Narrative

Corrected date of report submission to 06-jun-2023.

• Brand Name: UNIT,C6S 2.5,BTH
• Type of Device: C6 MCOT
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan MN
• Manufacturer (Section G): BRAEMAR MANUFACTURING, LLC; 1285 corporate center dr; suite 150; eagan MN
• MDR Report Key: 17040150
• MDR Text Key: 316325376
• Report Number: 2133409-2023-00024
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 06/01/2023
• 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