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

Model Number 02-01606

Device Problems Melted (1385); Excessive Heating (4030)

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

Event Type  malfunction  

Manufacturer Narrative

It was reported that the sensor case melted around the contacts.The device was returned and investigated and engineering evaluation was performed.Engineering evaluation was able to confirm melting event.Root cause is most probable to be damage to the mezzanine board connector which creating a fault condition in which caused the device to overheat and melt.

Event Description

It was reported that the sensor case melted around contact.No harm to he patient was reported.The device was returned for investigation.

• Brand Name: UNIT C6S 2.5 BTH
• Type of Device: UNIT C6S 2.5 BTH
• 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: 17308413
• MDR Text Key: 319112817
• Report Number: 2133409-2023-00037
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• 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
• Report Date: 07/12/2023

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
• Device Model Number: 02-01606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/12/2023
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: CHARGE ADPTR ASSY,BTP-1000S-C, (B)(6)