MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL THERMOGARD HQTM CONSOLE; THERMAL REGULATING SYSTEM

Model Number THERMOGARD HQ

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the thermogard hq console (b)(6) displayed an air trap alarm was confirmed in the event log data review but not confirmed during functional testing.The reported alarms were not replicated during testing, and the thermogard ivtm system functioned as intended.Upon visual inspection, the top lid was observed damaged, unrelated to the reported complaint.The probable cause could be due to mishandling.The top lid was replaced to address the observed issue.In addition, during the visual and functional inspection, the pump rotor was observed as rusted, likely caused by saline solution leaking from the suk.The pump rotor was replaced, as the rusted pump rotor can affect the functionality of the console.The event log showed an "alert saline empty" (2.5) occurred on the reported event date, confirming the customer's reported complaint.The "alert saline empty" happens if the air-trap saline level falls below acceptable levels during standby mode, typically suggesting a leak from the start-up kit (suk), as it was confirmed by the customer.The thermogard console passed initial functional testing without any fault or error after the top lid and the pump rotor were replaced.Following service, the thermogard console passed the final functional test and electrical safety test without any error.

Event Description

After two hours of ivtm therapy, and during the cooling phase of the treatment, the thermogard hq console (b)(6) displayed an air trap alarm, and a leakage of saline from the roller pump area was detected.Upon examination of the start-up kit (suk) (lot # unknown), it was noted that there was a skive cut in the suk tubing at the pump rotor.The temperature management therapy was continued with another tgxp console.No consequences or impact to the patient.

• Brand Name: ZOLL THERMOGARD HQTM CONSOLE
• Type of Device: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19016805
• MDR Text Key: 339112675
• Report Number: 3010617000-2024-00267
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/01/2024

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
• Device Operator: Health Professional
• Device Model Number: THERMOGARD HQ
• Device Catalogue Number: 601352-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1