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	Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the thermogard xp ivtm system (sn tgxp10347) was in warming mode at 35 degrees but suddenly began cooling.No additional information was provided.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.
Additional Manufacturer Narrative
The customer's complaint that the thermogard xp ivtm system (sn tgxp10347) was in warming mode at 35 degrees but suddenly began cooling was not confirmed during the functional testing and the event log review.No device malfunction was observed during the testing, and the thermogard system functioned as intended.The event log data indicated no errors, and no patient data was available in the log files.The thermogard system passed the functional testing with no issues.The customer-reported complaint was not reproduced during testing.The thermogard system is operating as intended.Following service, the thermogard xp ivtm system passed the final functional, calibration, and electrical safety tests without any issues.

• 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 ; +1(408)419-2347
• MDR Report Key: 50869701
• Report Number: 3010617000-2026-00582
• Device Sequence Number: 10715660
• 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): 09/23/2026

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: 08/28/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2011
• 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