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	Insufficient Information (4580)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint that the thermogard console (sn (b)(6) displayed the tcmid:05 (coolant diff failure) error message was confirmed based on the event log review but not during functional testing.The reported error was not replicated during testing, and the thermogard console functioned as intended.Nevertheless, the contacts of the lm34a/b internal temp probe on pic16 board and lower board were cleaned as a preventive measure, as intermittent technical problems may have occurred that could not be directly identified during functional testing.The event log review identified tcmid:05 error messages, confirming the reported complaint.The thermogard xp ivtm system passed functional testing, and the reported complaint was not reproduced.However, the contacts of the lm34a/b internal temp probe on the pic16 board and lower board were cleaned to prevent a recurrence of the error message.Following service, the thermogard console passed the final functional, calibration, and electrical safety tests without issues.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the thermogard console with sn (b)(6).
Event or Problem Description
The customer reported the thermogard console (sn (b)(6) displayed tcmid:05 (coolant diff failure) error.No information was shared with zoll about patient treatment status or if the system was intended for use on a patient or being tested.

• 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 ; 4084192347
• MDR Report Key: 25480626
• Report Number: 3010617000-2026-00357
• Device Sequence Number: 15944096
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2020
• 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