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	Insufficient Information (4580)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While preparing and inspecting the thermogard xp ivtm system (sn tgxp12184) for use, just prior to connecting the console to the patient, the customer noticed an unusual noise coming from the console's roller pump.As a result, the console was not used, and treatment was initiated with another console.It is unknown whether the reported issue caused any significant delay in treatment delivery.The patient's status information was requested, but the customer did not provide a response.
Additional Manufacturer Narrative
The thermogard xp ivtm system (sn (b)(6) was evaluated at the customer site.The reported complaint of unusual noise from the console's roller pump was confirmed during visual inspection and functional testing.The root cause was identified as a defective pump rotor head, likely resulting from wear and tear.The device's life expectancy is 5 years.The thermogard console was manufactured in january 2017 and is over 9 years old.Visual inspection revealed that one of the white roller guides was displaced, likely making noise by rubbing or scraping against the pump raceway.In addition, signs of wear were observed on the main roller, which may have contributed to noise generation during contact with the start-up kit (suk) tubing.These observations confirm the reported complaint, and the pump rotor head assembly needs to be replaced to address the issue.The thermogard xp ivtm system remained operational and passed preliminary functional testing.However, abnormal noise and looseness were noticed in the pump roller section, confirming the reported complaint.Replacement of the pump rotor head assembly is required to resolve the problem.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for the thermogard xp ivtm system with serial number (b)(6).

• 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: 25247956
• Report Number: 3010617000-2026-00325
• Device Sequence Number: 9724774
• 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): 05/21/2026

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: 04/30/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2017
• 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