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	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The thermogard xp ivtm system (sn (b)(6) was investigation at the customer site.The reported complaint that the thermogard xp ivtm system displayed a mid:23 (patient probe offset) error message was confirmed in both the system's event log data and during functional testing.The root cause was a defective input/output printed circuit board (i/o board), likely attributed to the device's aging.The device's life expectancy is 5 years.The thermogard console was manufactured in october 2015 and is over 10 years old.Review of the thermogard system's event logs showed several mid:23 (patient probe offset) error messages around the reported event date, confirming the reported complaint.The thermogard system failed the functional test with the mid:23 error message, confirming the reported complaint.Log data analysis showed periodic errors for mid:23 and primary temperature probe offset check.The patient temperature probe was replaced at the hospital, and the customer confirmed that there were no problems with the temperature probe.Following the replacement of the i/o board by service, it was confirmed that mid:23 did not recur.As a preventive measure, the t1 and t2 input block was also replaced.Subsequent calibration and inspection procedures were completed, confirming normal system operation.Following service, the thermogard system passed all testing and inspection 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 console with serial number (b)(6).
Event or Problem Description
During the rewarming phase of ivtm therapy, the thermogard xp ivtm system (sn (b)(6) displayed a mid:23 (patient probe offset) error message.No troubleshooting was performed.No alternate console or competitor device was used, and the treatment was completed.No consequences or impacts on the patient.

• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose 95131 ; 4084192347
• MDR Report Key: 25382176
• Report Number: 3010617000-2026-00339
• Device Sequence Number: 9204597
• 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): 06/03/2026

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: 05/10/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2015
• 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