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	Visual Prompts will not Clear (2281); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The thermogard hq temp mgt console involved in the reported complaint will not be returned for evaluation, as biomed performed functional testing for several hours and the console functioned without issue.Therefore, the service was not required to be performed by zoll.
Event or Problem Description
During ivtm therapy, the thermogard hq temp mgt console (sn (b)(6) displayed an error message.The customer was unable to specify the nature of the error but mentioned that the console was alarming and then shut off.No additional information was provided by the customer.The patient's status information was requested, but the customer did not provide a response.

• 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: 23897953
• Report Number: 3010617000-2025-00885
• Device Sequence Number: 10374884
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/26/2025

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: 12/02/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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