MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. THERMOGARD XP®; INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM

Model Number	THERMOGARD XP, LANG SET A, NON-ROHS
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During ivtm therapy utilizing the thermogard console (sn (b)(6), quattro catheter (lot #217027), and the start-up kit (suk) (lot #219591), an air trap alarm was triggered.A saline leak was suspected due to a noticeable decrease in saline volume in the bag.Per the instructions for use (ifu), the catheter was checked for leakage.Subsequently, the console displayed a mid:13 (bg adc) error message.In response, a new suk was installed on a different console, and the catheter was replaced; the temperature management therapy was resumed.No patient injury or adverse effects were reported.
Additional Manufacturer Narrative
The customer's complaint that the thermogard console (sn (b)(6) displayed an air trap alarm was confirmed during the functional testing.The root cause of the error message was a failed air trap sensor block due to a leaking start-up kit (suk).The reported secondary complaint that the console displayed a mid:13 (bg adc) error was not confirmed during the functional testing.The reported error was not reproduced during the testing.The event log was not downloaded for review.The thermogard console failed the initial functional test because the liquid level in the air trap could not be properly detected.The air trap sensor block needs to be replaced to address the error.Waiting for customer approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the thermogard xp ivtm system with sn (b)(6).

• Brand Name: THERMOGARD XP®
• 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: 25574756
• Report Number: 3010617000-2026-00377
• Device Sequence Number: 9065086
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K072234
• 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): 06/22/2026

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: THERMOGARD XP, LANG SET A, NON-ROHS
• 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: 05/25/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2017
• 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