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

Model Number THERMOGARD HQ

Device Problems Insufficient Cooling (1130); Insufficient Heating (1287)

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

Event Date 10/13/2023

Event Type  malfunction  

Event Description

As reported, during the treatment with the thermogard hq console (sn (b)(6).), the patient's temperature increased rapidly and decreased slowly, despite employing a controlled rate of 0.25 degrees celsius per hour.The patient's temperature increased at a rate of 1 degree per hour, and it took 16 hours to lower their temperature by 4 degrees.Despite the extended cooling time, the therapy was completed with the same console.No consequences or impact to the patient.

Manufacturer Narrative

The thermogard hqtm console (sn (b)(6).) was evaluated by zoll service at the customer site.The customer's reported complaint of fast warming and slow patient cooling during the treatment with the console was not confirmed during the functional testing and the archive data review.No device malfunction was noted during the testing, and the console functioned as intended.Upon visual inspection, no physical damage was observed.Unrelated to the reported complaint, observed a non-zoll gray amc temperature cable connected to the t1 input of the console.A review of the event log showed the presence of the mid:14 (bg power supply), and mid:16 (software) errors, unrelated to the reported complaint.The possible root cause of both mid:14 and mid:16 errors was most likely triggered by quick powering off/on the thermogard console, which did not let the system's software have enough time to reset.The thermogard console passed the functional testing without errors and functioned as intended throughout the testing.The customer's reported complaint was not reproduced, thus not confirming the customer's reported complaint.The probable cause for the customer's reported complaint was likely due to the use of a non-zoll temperature cable during the treatment that might have generated incorrect readings.The customer was instructed to use a proper temperature cable with the console.The thermogard console passed the final functional test without issues upon service.

• 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: kim nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18137515
• MDR Text Key: 328123627
• Report Number: 3010617000-2023-00966
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• 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
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2023
• 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