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	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During induced hypothermia on a patient, a component inside the roller pump of the thermogard hq console (sn (b)(6) broke, creating a sharp edge.This sharp edge cut the roller tubing on the start-up kit (suk), causing saline to leak onto the floor.As a result, an air trap alarm was triggered, and the cooling process for the patient was stopped.The patient's status information was requested, but the customer did not provide a response.
Additional Manufacturer Narrative
G4: pma/510(k): premarket submission number not available/not released the thermogard hq temp mgt console (sn (b)(6) was investigated by zoll service personnel at the customer's site.The reported complaint that the thermogard hq console displayed an air trap alarm after saline leaked from the start-up kit (suk) was confirmed in the system's log data file.A visual-functional inspection confirmed the reported complaint that a component inside the roller pump of the thermogard hq console broke, creating a sharp edge and causing a cut in the roller tubing on the suk and saline leakage.The root cause was the broken white roller guide on the calibrated pump rotor.Reviewing the event log showed no hard error messages, but it revealed multiple "alarm_air_trap_warning" (1.5) alerts noted around the reported event date, confirming the reported complaint.The preliminary functional test was not performed due to the broken white roller guide.The console's calibrated rotor, collet, and pump knob were all replaced because dried saline was found in the rotor assembly, resulting from the saline spill in the raceway.After these replacements, the thermogard hq console successfully passed both the preliminary and subsequent functional tests.Following service, the thermogard hq system passed all testing criteria.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 temp mgt 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: kim thoa sackrison ; 2000 ringwood ave.; san jose 95131 ; 4084192347
• MDR Report Key: 21946173
• Report Number: 3010617000-2025-00309
• Device Sequence Number: 21041748
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/01/2025

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: 04/07/2025
• Initial Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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: Unknown