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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported leakage in the thermogard xp ivtm system ((b)(6) with no further information.The customer used another thermogard console to continue treatment.The patient was not in danger.
Additional Manufacturer Narrative
The thermogard xp ivtm system (b)(6) was investigated at the customer's site.The reported complaint of leakage in the thermogard system was not confirmed in the system's log data files and was not replicated during functional testing.No device malfunction was found, and the thermogard console functioned as intended.Review of the system's log data files showed no issues or error messages.The thermogard ivtm system passed functional tests and performed without any issues.Following service, the thermogard system passed all testing criteria.

• 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: 25402734
• Report Number: 3010617000-2026-00350
• Device Sequence Number: 10302394
• 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): 06/04/2026

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: 05/12/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2020
• 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