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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint that the thermogard xp ivtm system (sn (b)(6)) displayed a tcmid:06 (ce post failure) error message after starting up was confirmed during the event log review and functional testing.The root cause of the reported error message was a failure of the cooling engine (ce).The event log review indicated tcmid:06 error messages, thus, confirming the customer's reported complaint.The thermogard system failed preliminary functional testing due to the tcmid:06 error message displayed during post, thus, confirming the customer's reported complaint.The heater was checked and the temperature fuse was reset, but the error was not cleared.The cooling engine was observed to be leaking, and it sporadically did not stop the heating phase.The cooling engine assembly needs to be replaced to address the tcmid:06 and leak.Due to the age of the device, it will not be repaired.The customer will scrap the device.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaints were reported for thermogard xp ivtm system with sn (b)(6).
Event or Problem Description
The customer reported the thermogard xp ivtm system (sn (b)(6)) displayed a tcmid:06 (ce post failure) error message after starting up.The customer used a second thermogard to continue the treatment.No impact or consequence to the patient.

• 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: 25448215
• Report Number: 3010617000-2026-00352
• Device Sequence Number: 5763939
• 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): 06/09/2026

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: 05/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2012
• 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