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	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported on the thermogard xp ivtm system (sn (b)(6), a mid:09 (air trap assembly) error message occurs, and even though coolant is present, the console indicates that the coolant level is low.This issue occurred before patient use.The errors were displayed immediately upon powering on the console.Treatment was started using a replacement unit.No impact or consequence to the patient.
Additional Manufacturer Narrative
The reported complaint that the thermogard xp ivtm system (sn (b)(6) displayed mid:09 (air trap assembly) error message was confirmed during functional testing and archive data review.The secondary complaint that even though coolant is present, the console indicates that the coolant level is low was confirmed during functional testing.The root cause of the error messages was due to a failure of the coolant block assembly.Event log data review was performed and revealed mid:09 (air trap assembly) error messages; thus, confirming the reported complaint.The thermogard console failed the initial functional test due to mid:09 error message, thus confirming the reported complaint.During the investigation, while repeatedly cycling the power on and off, the "no coolant" message appeared once, confirming the secondary complaint.After that, only the mid:09 message was observed.The coolant block assembly functions as a sensor that detects the coolant level.When this component fails, messages such as "low coolant" or "no coolant" may appear on the screen even when there is no actual issue with the coolant level, and this may subsequently result in a mid:09 being recorded.In this case, the primary issue was the unstable behavior of this component, which caused it to detect a decimal value outside the specified range, neither "empty" nor "low", and triggered mid:09.Related the reported complaint, some of the leds mounted on the coolant block sensor printed circuit board (pcb) did not illuminate, likely due to a failed component.The coolant block assembly was replaced to address both reported complaints and to resolve the led issue.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 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: 25526341
• Report Number: 3010617000-2026-00371
• Device Sequence Number: 5560246
• 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): 06/16/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2018
• 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