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 Codes	Display or Visual Feedback Problem (1184); Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the thermogard xp ivtm system (sn (b)(6) is showing an excessive deviation between the set point and actual temperatures was not confirmed during the review of the event log or functional testing.The complaint that the console experienced a pump failure was also not confirmed during review of the event log or functional testing.The reported issues were not replicated during testing, and the console functioned as intended.Upon review of the event log, no irregularities were found.The thermogard console passed the initial functional testing without any fault or error.The reported complaint was not reproduced.The cables were checked and the console was connected to an external monitor.There was no deviation in temperature, and the pump was turning as it should.The console performed as intended.It is possible that the cable was inadequately connected to the monitor interface by the customer during the reported event.Following service, the thermogard console passed all subsequent functional and electrical tests with no issues, and readings were within the specified limits.
Event or Problem Description
The customer reported the thermogard xp ivtm system (sn (b)(6) is showing an excessive deviation between the set point and actual temperatures.The device is also reported to have experienced a pump failure without triggering an alarm.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

• 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: 25699456
• Report Number: 3010617000-2026-00408
• Device Sequence Number: 9720374
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

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: 06/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2014
• 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