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	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during ivtm (intravascular temperature management) therapy utilizing the thermogard hq console (sn (b)(6) in conjunction with a quattro catheter, the patient failed to reach the target temperature.In addition, the cooling rate was too low.Although an air trap alarm was triggered during the maintenance phase, no prior alarms were recorded in the system logs.A review of the eeg (electroencephalogram) log revealed no evidence of shivering-related artifacts, and nursing staff observed no clinical signs of shivering at the bedside.The same patient was subsequently connected to a different thermogard console in the emergency department, where target temperature was successfully maintained.No consequences or impact to the patient.
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) was evaluated by zoll service at the customer site.The customer reported a complaint that the patient failed to reach the target temperature, and the cooling rate was too low during the treatment was not confirmed during the functional testing and the archive data review of the thermogard hqtm console.No device malfunction was noted during the testing, and the console functioned as intended.A review of the event log showed no significant discrepancies.The thermogard hq console passed the functional testing without errors and functioned as intended throughout the testing.The thermogard hq console passed the final functional test without issues upon service.

• 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: 22697706
• Report Number: 3010617000-2025-00524
• Device Sequence Number: 12998011
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 08/04/2025

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: 07/09/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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