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	Smoking (1585); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11 (provide narrative/ data) was updated.(umbilical cable assembly will also be replaced to remedy the complaint.) the thermogard console failed functional testing and was rendered inoperable due to a defective, opened umbilical cable and a melted/burnt power cable connected to the i/o pcb, confirming the reported complaint.The power supply assembly and umbilical cable assembly were replaced to remedy the reported complaint.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.Per the biomed, there was no safety issue or concern from the smoke.The reported complaint that the thermogard hq temp mgt console (sn (b)(6)) powered down with no alarm and their smoke from the system was confirmed during visual inspection and functional testing.The cable from the power supply connected to the i/o pca was burnt.The root cause of the burnt power supply cable was identified as an internal short within the power supply.The thermogard console failed functional testing and was rendered inoperable due to a defective, opened umbilical cable and a burnt power cable connected to the i/o pcb, confirming the reported complaint.The power supply assembly needs to be replaced to remedy the reported complaint.Waiting for customer approval for repair.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).
Event or Problem Description
After two hours of running, the thermogard hq temp mgt console (sn (b)(6)) powered down with no alarm.Smoke was seen coming out of the vent side of the system.Per the biomed, there was no safety issue or concern from the smoke.Another system was used to continue treatment.No harm to patient.

• 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: 24692484
• Report Number: 3010617000-2026-00172
• Device Sequence Number: 15866508
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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