MAUDE Adverse Event Report: ZOLL CIRCULATION, INC THERMOGARD HQTM CONSOLE; INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM

Model Number	THERMOGARDHQ, LANG SET A
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The reported complaint that the thermogard hq console (sn (b)(6)) emitted an audible "air trap fault" alarm was confirmed during visual inspection but not during functional testing.No device malfunction was found during the device inspection.There was an accumulation of saline solution inside the pump raceway.The reported fault was due to saline spillage into the console pump raceway, attributed to a leak of the start-up kit, which was used at the time of the event.The ivtm thermogard console passed the initial functional testing without any fault or error.The reported complaint of an air trap fault was not reproduced.Upon inspecting the inside of the console, there was no evidence of saline solution infiltration.The led on the raceway was functioning properly.However, the raceway was cleaned to remove the accumulation of saline solution.Following service, the thermogard console passed all subsequent functional and electrical tests with no issues, and readings were within the specified limits.
Event or Problem Description
On july 11, during patient use using the thermogard hq console (sn (b)(6)) and the start-up kit (suk), (lot 200280), the console emitted an audible "air trap fault" alarm.The customer stopped using the console.Therapy was continued using a blanket.No adverse effects on the patient.
Additional Manufacturer Narrative
H11 (provide narrative/ data) was corrected.The reported complaint that the thermogard hq console (sn (b)(6) emitted an audible "air trap fault" alarm was not confirmed during functional testing.No device malfunction was found during the device inspection.The reported fault was due to saline spillage into the console pump raceway, attributed to a leak of the start-up kit, which was used at the time of the event.When there is an suk leak, the console is designed to emit an air trap fault.The ivtm thermogard console passed the initial functional testing without any fault or error.The reported complaint of an air trap fault was not reproduced.Upon inspecting the inside of the console, there was no evidence of saline solution infiltration.The led on the raceway was functioning properly.However, the raceway was cleaned to remove the accumulation of saline solution, attributed to an suk leak, which was confirmed upon investigation of the returned suk.Following service, the thermogard console passed all subsequent functional and electrical tests with no issues, and readings were within the specified limits.

• Brand Name: THERMOGARD HQTM CONSOLE
• Common Device Name: INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131
• MDR Report Key: 22744828
• Report Number: 3010617000-2025-00526
• Device Sequence Number: 20653769
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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
• Operator of Device: Health Professional
• Device Model Number: THERMOGARDHQ, LANG SET A
• Device Catalogue Number: 8700-001030-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown