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	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during setup for treatment, when powering up the thermogard hq temp mgt console (sn (b)(6), the system showed a "coolant low" alarm despite a full coldwell of coolant level.The customer then turned off the thermogard hq system and turned it back on.After restarting, the hq console displayed an unknown error message.Another system was used to treat the patient.No consequences or impacts on the patient.
Additional Manufacturer Narrative
G4: pma/510(k): premarket submission number not available/not released.Zoll service performed an on-site evaluation of the thermogard hq console (sn (b)(6).The customer reported that the thermogard hq console displayed a "coolant low" alarm.Although this alarm did not appear during functional testing, the issue was confirmed through visual and functional inspection.The root cause was identified as the defective coolant block sensor, likely due to defective component(s).The customer reported that after restarting the console, it showed an unknown error message.The system event log data showed a couple of mid:09 (glycol assembly) error messages on the reported event date.Although this error could not be replicated during functional testing, the investigation confirmed that it was triggered during the reported event by the defective coolant block sensor.During functional testing, the coolant block sensor was not working correctly, as there was a non-functional led on the sensor pcb.The "coolant low" alarm was not duplicated during testing; however, it was caused by the defective coolant block sensor, which was replaced to remedy the issue.Following service, the thermogard hq system passed all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the thermogard hq temp mgt console with serial number (b)(6).

• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose 95131 ; 4084192347
• MDR Report Key: 22909403
• Report Number: 3010617000-2025-00591
• Device Sequence Number: 8851516
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2024
• 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