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	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the start-up kit (suk) (lot unknown) was damaged in pump rotor of the thermogard hq console (sn (b)(6)).The system was taken out of use for investigation and resolution.No additional information was provided.No information was shared with zoll about patient treatment status or if the system was intended for use on a patient or being tested.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.Zoll has not received the thermogard hq console in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Additional Manufacturer Narrative
The reported complaint that the start-up kit (suk) was damaged in the pump rotor of the thermogard hq console (sn (b)(6) was confirmed during visual inspection and functional testing.The root cause for the reported complaint is that the gap between pump rotor and hosing was too small, related to a failure of the pump rotor.This led to damage to the suk hosing.During visual inspection of the thermogard hq console, it was observed that the gap between the pump rotor and hosing was too small, related to the reported complaint.The thermogard console failed the initial functional test due to the failed gap test.The pump rotor head assembly was replaced to remedy the reported complaint.Subsequently, the gap check verified the gap was within specification.Following service, the thermogard console passed all tests with no issues, and readings were within the specified limits.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for thermogard hq console with sn (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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131
• MDR Report Key: 24397080
• Report Number: 3010617000-2026-00093
• Device Sequence Number: 9802681
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 03/24/2026

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: 01/28/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• 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