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	No Display/Image (1183); Noise, Audible (3273); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the rewarming phase, the thermogard hq console (sn (b)(6) powered off unexpectedly.After turning the power back on, the fan can be heard running, but the screen remains completely blank and the roller pump is not operating, making the device unusable.An alarm sounds whenever any button is pressed.Therapy was continued using another console.No patient injury reported.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released the reported complaint that thermogard hq console (sn (b)(6) was switched on but the screen remains completely blank was confirmed during functional testing.The complaint was resolved by reconnecting the lcd board connector to the pcb in the display head; however, the entire display head was replaced as a precaution.The reported complaints that the console powered off unexpectedly and that an alarm sounds whenever any button is pressed were not confirmed during review of the event log or functional testing.The thermogard hq console failed the initial functional test.The customer's reported complaint about a blank screen was confirmed.The processor board was replaced but this did not resolve the issue.The reported complaint was resolved by reconnecting the lcd to the pcb in the display head.However, as a precaution, the entire display head was replaced.The reported complaint that the console powered off unexpectedly was not reproduced.All the buttons and sounds also worked as intended.Following service, the thermogard console passed all tests with no issues, and readings were within the specified limits.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 serial number (b)(6).

• 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: 25602613
• Report Number: 3010617000-2026-00390
• Device Sequence Number: 5533909
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• 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