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

Model Number 8700-0650

Device Problem Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

The thermogard console was evaluated by zoll service personnel at the customer site.The reported complaint of the thermogard console (sn (b)(6)) displayed a mid:09 (air trap assembly) error message was confirmed based on the event log review and during functional testing.The root cause of the mid:09 error was the defective air trap sensor board due to a possible overflow of fluid into the air trap chamber, likely attributed to user mishandling.There was no history of start-up kit (suk) leak complaints reported by this customer.No physical damage was observed on the thermogard console during visual inspection.An event log data review was performed and revealed multiple mid:09 (air trap assembly) error messages, confirming the reported complaint.During functional testing, the thermogard console displayed a mid:09 (air trap assembly) error message upon powering up, confirming the reported complaint.Observed dried saline traces on the air trap sensor board.The defective air trap sensor board was replaced to address the customer's reported complaint of mid:09.Following service, the thermogard console passed the final functional test and electrical safety tests without any error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the thermogard console with serial number (b)(6).

Event Description

As reported, the thermogard console (sn (b)(6)) displayed a mid:09 (air trap assembly) error message.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

• 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: 17814582
• MDR Text Key: 324228840
• Report Number: 3010617000-2023-00825
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/25/2023

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: 8700-0650
• Device Catalogue Number: 8700-0650
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2014
• 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