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	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The customer's complaint that the start-up kit (suk) lfl tubing around the roller pump ruptured, causing saline to spurt from the tubing into the roller pump of the thermogard hq console (sn (b)(6) was confirmed during the visual inspection.The roller pump knob on the console was the old type, which caused the suk tube to rupture.Upon visual inspection, it was confirmed that normal saline had accumulated in the pump raceway.The console interior was also inspected, but no infiltration of normal saline was observed.The saline traces were cleaned, and the old roller pump knob was replaced with the new version to address the reported complaint.Following cleaning and part replacement, the thermogard hq console passed the functional testing without error.Following service, the thermogard hq console passed the final functional and electrical safety tests without any issues.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the thermogard hq console with sn (b)(6).
Event or Problem Description
During ivtm therapy, the start-up kit (lot # 200280) lfl tubing around the roller pump ruptured, causing saline to spurt from the tubing into the roller pump of the thermogard hq console (sn (b)(6).Because the roller pump was filled with saline, the customer stopped using the thermogard hq console and switched to a system from another manufacturer to continue temperature management.The roller pump knob on the console was of the old type.No patient injuries were reported.

• 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: 23480674
• Report Number: 3010617000-2025-00759
• Device Sequence Number: 10227888
• 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): N
• 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): 11/05/2025

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: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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