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

Model Number	THERMOGARDHQ, LANG SET A
Medical Device Problem Codes	Insufficient Heating (1287); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The customer's complaint that the roller pump of the thermogard hq console (sn (b)(6) stopped rotating was confirmed based on the event log data.The event log shows multiple alarms on the event date, including 1.1.0 - t1 disconnected during run and 1.4.0 - roller pump door open.These alarms may have caused the roller pump to stop operating due to the system's default settings.No hardware error codes were recorded in the event log.Further investigation is ongoing to determine the potential root cause.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
An ivtm therapy was started on (b)(6) 2025, at 07:03 pm using the thermogard hq console (sn (b)(6) to rewarm a patient.The target temperature was set to 36 degrees celsius at a rate of 0.1 °c/hr.During the cooling phase, the customer noted that the start-up kit (suk) flow indicator was not spinning, and the temperature was not displayed on the monitor.Additionally, the customer reported that the roller pump of the thermogard hq console stopped rotating at some point, and rewarming therapy wasn't as intended.The customer observed that the patient's temperature was rising steadily and reached 34.1 degrees celsius until approximately 7:00 am on (b)(6) 2025.I then suddenly dropped to 33.7 degrees celsius and remained below 34.1 degrees celsius, only rising again at 11:00 am.On (b)(6) 2025, at 7:07 pm, the controlled rate increased to 0.2/hr.No patient injury was reported.
Additional Manufacturer Narrative
The customer's complaint that the roller pump of the thermogard hq console (sn (b)(6) stopped rotating was confirmed based on the event log data but not confirmed during the functional testing.No device malfunction was observed during the testing and the system functioned as intended.The start-up kit (suk) used during the reported event was not returned to zoll for investigation.The event log indicated multiple warning messages on the event date, including 1.1.0 - t1 disconnected during run and 1.4.0 - roller pump door open.These alarms may have caused the roller pump to stop operating due to the system's default settings.No hardware error codes were recorded in the event log.The thermogard system passed the functional testing and the warning messages noted in the event log were not reproduced during the testing.The thermogard system functioned as intended.The system passed the complete functional check, including system slew rate test.The system performed within specification and did not display any error messages or anomalies.

• 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 ; 4084192347
• MDR Report Key: 23031790
• Report Number: 3010617000-2025-00645
• Device Sequence Number: 9514721
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 10/09/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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