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	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint that the thermogard xp ivtm system (sn (b)(6) displayed tcmid:06 (ce post failure) error message was confirmed during the functional testing and the archive review.The likely root cause of the reported complaint was a failure of the lm34 temperature sensor.The event log review indicated tcmid:06 errors, confirming the reported complaint.Related to the reported complaint, tcmid:08 (coolant temp low) error message was also observed in the log.During functional testing, the thermogard xp ivtm system did not pass the power-on self-test and displayed a tcmid:06 error upon powering on, confirming the reported complaint.The lm34 temperature sensor was replaced to remedy the reported complaint.The tcmid:08 observed in the event log was not reproduced but replacement of the lm34 temperature sensor will also prevent recurrence of the error message.Following service, the thermogard xp ivtm system passed the final testing without any error.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for thermogard xp ivtm system with sn (b)(6).
Event or Problem Description
Biomed reported the thermogard xp ivtm system (sn (b)(6) displayed tcmid:06 (ce post failure) error message.Another device was used for therapy.The patient was not in danger.No further information.

• 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: 25310613
• Report Number: 3010617000-2026-00328
• Device Sequence Number: 13231783
• 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): 05/27/2026

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: 05/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2014
• 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