MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM THERMOGARD XP; THERMAL REGULATING SYSTEM

Model Number 8700-0650

Device Problem Insufficient Cooling (1130)

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

Event Date 06/25/2023

Event Type  malfunction  

Manufacturer Narrative

The thermogard console (sn (b)(6)) was received for evaluation, however, the investigation is pending.A follow-up report will be filed when the investigation has been completed.

Event Description

On june 23, the thermogard console (sn (b)(6)) was set up in "pre-cool" mode at 12:00 pm.Therapy began in "max" mode at 14:15, with a target temperature of 37 degrees celsius and a patient temperature of 38 degrees celsius.At 16:00, the coolant well temperature did not decrease, so the target temperature was changed to 36 degrees celsius.The console filter was cleaned at 16:20.At 17:00, there was still a gap between the target temperature and the patient temperature, and the coolant well temperature had not yet decreased.The console use was discontinued, and another console was utilized to properly cool the patient and continue the therapy.No consequences or impact to the patient.

Manufacturer Narrative

The customer reported a complaint that "the thermogard console (sn (b)(6)) took more time to reach the target temperature" was confirmed based on the review of the patient data log but not during the functional testing.The root cause of the reported issue could not be conclusively determined as the reported issue was not duplicated during the functional testing, and the thermogard console functioned as intended.During visual inspection, no physical damage was observed on the thermogard console.During the event log review, no significant discrepancies were noted.However, the patient data review noted that the patient was not cooled, thus confirming the customer's complaint.The functional and calibration tests were performed, and no issue was observed.The resistance of the compressor was measured and found to be within the acceptable range.The j22/p22 connectors of the pic 16 board were checked with no problem found.The console passed all tests, and the temperature reading inputs were correct.No device malfunction was noted.

• Brand Name: ZOLL IVTM THERMOGARD XP
• 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: 17386426
• MDR Text Key: 319986337
• Report Number: 3010617000-2023-00615
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0650
• Device Catalogue Number: 8700-0650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2023
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2017
• 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