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	Insufficient Cooling (1130); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The customer's reported complaint that the thermogard hq temp mgt console (sn (b)(6)) was set to 33 degrees, and the patient was at 34.1 degrees, but the device wouldn't cool beyond 34.1 degrees and the roller pump stopped was not confirmed during the functional testing or review of the event log.The reported issue was not replicated during testing, and the console functioned as intended.Upon review of the event log, no irregularities were found.The thermogard hq temp mgt console passed the functional test without any fault or error.The system is working as intended.Following service, the thermogard console passed all subsequent functional and electrical tests with no issues, and readings were within the specified limits.
Event or Problem Description
The customer reported that during the cooling phase of therapy, the thermogard hq temp mgt console (sn (b)(6)) was set to 33 degrees, and the (b)(6), 144cm, 52.2kg female patient was at 34.1 degrees, but the device wouldn't cool beyond 34.1 degrees.The patient temperature at the start of therapy was 33.9 c.The roller pump stopped.No error messages were displayed on the console.Therapy had been started at approximately 21:00 on (b)(6) and the console stopped around 12:00 on (b)(6).They tried switching temperature probes from t1 to t2, utilizing esophageal and bladder temp probes but the issue persisted.The clinicians obtained another console and continued treatment for the patient using the second console without any issues.The same catheter was used to continue therapy.There were no adverse effects to the 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: 22137691
• Report Number: 3010617000-2025-00373
• Device Sequence Number: 15491271
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/03/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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: Female
• Patient Weight: 52 KG