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	04/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released as it is exempt from premarket submission.The thermogard hq console (sn (b)(6)) associated with the reported complaint will not be returned for evaluation.The distributor was advised to perform the following remedial actions: ensure the roller pump lid was fully secured; confirm that no led indicators remained illuminated after the lid was closed; and verify that the suk was properly installed in the roller pump compartment.Following implementation of the recommended actions, the distributor confirmed that the console operated as intended, passed functional testing without errors, and no further error messages were observed.Based on this information, the service was not required to be performed by zoll.The thermogard hq console was determined to be functional and was returned to clinical use.
Event or Problem Description
During shift check, the customer reported that the thermogard hq ivtm console (sn (b)(6)) displayed pump stop alert error message intermittently.No patient involvement.

• 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: 25130944
• Report Number: 3010617000-2026-00286
• Device Sequence Number: 18464810
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2025
• 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