MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. THERMOGARD HQTM CONSOLE; INTRAVASCULAR CORE TEMPERATURE REGULATION SYSTEM

Model Number	THERMOGARDHQ, LANG SET A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During the incoming inspection of the thermogard hq console (sn (b)(6) at the azm warehouse, zoll tech service personnel noticed that one (blue line) of the cables labelled p22 was pulled inside.Also, one (brown, 6) of the cables labelled p21 was pulled inside.No patient involvement.
Additional Manufacturer Narrative
For g4: pma/510(k): premarket submission number not available/not released.The thermogard hq console is under investigation at zoll.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
During the incoming inspection of the thermogard hq console (sn (b)(6) at the azm warehouse, zoll technical service personnel noticed that one of the cables labeled p22 (blue line) had been pulled inside.Also, one brown cable (6) labeled j21 was pulled inside.No patient involvement.
Additional Manufacturer Narrative
B5 (describe event or problem) was updated.During the incoming inspection of the thermogard hq console (sn (b)(6) at the azm warehouse, zoll technical service personnel noticed that one of the cables labeled p22 (blue line) had been pulled inside.Also, one brown cable (6) labeled j21 was pulled inside.The p22 connector was replaced, and the wiring on the j21 connector was seated correctly to address the observed problem.Following the replacement, the thermogard hq console passed the final test without issue.

• Brand Name: THERMOGARD HQTM CONSOLE
• 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 ; 4084192347
• MDR Report Key: 24968575
• Report Number: 3010617000-2026-00253
• Device Sequence Number: 21477794
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: THERMOGARDHQ, LANG SET A
• Device Catalogue Number: 8700-001030-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2026
• 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