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 04/03/2023

Event Type  malfunction  

Event Description

The customer reported that during patient treatment, they noticed the thermogard xp ivtm system (sn (b)(6)) had "cooling issues".The customer did not provide any further information.It is unknown if the treatment was continued.The patient's status information was requested, but the customer did not provide a response.

Manufacturer Narrative

Zoll service evaluated the thermogard xp ivtm system (sn (b)(6)) at the customer site.The reported complaint that the thermogard system had "cooling issues" was not confirmed in the system's event log or during functional testing.No device malfunction was found, and the thermogard console functioned as intended.During visual inspection, zoll service personnel noted that the console's top cover deck was cracked near the air trap holder.This observation was unrelated to the reported complaint and can be attributed to user mishandling.The customer was informed of the issue and advised that the damaged top cover deck should be replaced to address the issue.The system's event log was reviewed and showed several tcmid:05 (coolant diff failure) error messages, unrelated to the reported complaint.The thermogard ivtm system passed all functional tests and performed within the specification without a fault or error.The tcmid:05 error messages, noted in the log files, could not be replicated during functional testing and possibly were caused by an intermittent electrical connection from the system temperature probes.During device evaluation, multiple cable connections were examined and reconnected as a preventive measure against future recurrences of this issue.Following service, including preventive maintenance actions, the thermogard console passed all tests with no issues, and readings were within the specified limits.

• 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 thoa nguyen ; 2000 ringwood ave.; san jose 95131 ; 4084192922
• MDR Report Key: 16820828
• MDR Text Key: 314077873
• Report Number: 3010617000-2023-00376
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• 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: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• 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