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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released zoll has not received the thermogard hq temp mgt console in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
The customer reported during use of the thermogard hq console (sn (b)(6) the target temperature was 37 but when the patient's temperature hit 36.7, the console changed to maintenance mode.The customer stated she then went to standby mode and changed her target temperature to 37.3.The patient's temperature went to 36.8 and the console didn't go to maintenance mode.Subsequently, the target temperature was changed back to 37 degrees and the console initiated maintenance mode at 36.7 degrees, stating the target temperature was reached.She believes the unit is off by 0.3 degrees.The console was used to continue therapy in maintenance mode for the rest of her shift.No impact or consequence to the patient.
Additional Manufacturer Narrative
This supplemental mdr is being sent to retract the initial mdr submitted for this reported event.According to correspondence with (b)(6), the console enters maintenance mode once the patient's temperature is 0.5c from target temperature, so the condition described by the user is expected.The console functions as intended and the event was downgraded to a non-complaint.This information was sent to the zoll clinical educator so they can re-educate the customer.

• 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: 23984633
• Report Number: 3010617000-2026-00012
• Device Sequence Number: 4553906
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/23/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 02/08/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/23/2026
• 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