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

Model Number 8700-0650

Device Problem Insufficient Cooling (1130)

Patient Problem Insufficient Information (4580)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

During ivtm therapy, the thermogard ivtm system (sn (b)(6)) reaches the target temperature for the patient with little or significant delays.The target temperature was 34,5 degree celsius at maximum cooling mode, and within 3 hours, the patient temperature was not under 34,77 degree celsius.Patient's status information was requested but the customer did not provide a response.

Manufacturer Narrative

The customer reported a complaint that "the thermogard ivtm system (sn (b)(6)) reaches the target temperature for the patient with little or significant delays" 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 test was performed, and no issue was observed.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
• MDR Report Key: 17739506
• MDR Text Key: 323323507
• Report Number: 3010617000-2023-00774
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2018
• 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