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 08/22/2023

Event Type  malfunction  

Event Description

During ivtm therapy, customer reported that the thermogard ivtm system (serial #(b)(6) ) displayed "air trap" warning message.It is unknown if another temperature management was use to continue with treatment.Patient's status information was requested but the customer did not provide a response.

Manufacturer Narrative

The customer's complaint of "the thermogard ivtm system (serial #(b)(6)) displayed "air trap" warning message" was not confirmed during the functional testing but confirmed during the archive data review.The root cause of the reported complaint was the failed air trap sensor block, likely attributed to the age of the device and/or saline overflow into the air trap holder caused by a leaking start-up kit (suk) which occurred in (b)(6) 2022.The thermogard ivtm system was manufactured in 2017 and has passed its service life of 5 years.No physical damage was observed on the thermogard system during the visual inspection.The event log data revealed air trap warnings, thus confirming the reported complaint.The thermogard system passed the initial functional test without any fault or error.The reported "air trap" warning message" was not reproduce, however, the air trap sensor block was replaced as a preventive precautionary measure.Following service, the thermogard xp ivtm system passed the final functional, calibration, and electrical safety tests without issues.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the thermogard xp ivtm system with serial number (b)(6).

• 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: 17739389
• MDR Text Key: 323321939
• Report Number: 3010617000-2023-00780
• 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

• 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
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2017
• 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