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

Model Number 8700-0650

Device Problems Insufficient Heating (1287); Visual Prompts will not Clear (2281)

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

Event Date 10/04/2023

Event Type  malfunction  

Manufacturer Narrative

The thermogard console (b)(6) involved in the reported complaint was not returned for investigation; however, the event and patient logs were reviewed by zoll service personnel to investigate the customer-reported complaint.The customer reported a complaint that "the console slowly rewarming the patient and displayed the alarms" was confirmed based on the review of the event and the patient logs.The potential root cause for the reported complaint could be a loose or failed temperature cable, likely attributed to a failed component or degradation from age or usage.The thermogard console was manufactured in december 2017 and is almost 6 years old, past the expected service life of 5 years.The event log indicated a t1 temperature input temperature of 26°c, which explains the alarms generated by the console.Therefore, the potential root cause of the reported complaint could be a loose or failed temperature cable.Zoll service personnel recommended the customer replace the temperature cable.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 (b)(6).

Event Description

During ivtm therapy, the catheter was placed in the patient's femoral vein smoothly after the first attempt.After three days of therapy, the console was placed in a rewarming mode after successful hypothermia; however, after half of the day, the patient's target temperature of 36.0 °c had not been reached.In addition, the thermogard console (b)(6) displayed multiple alarms without showing any error messages.The patient's temperature was 35.5°c when the system was inspected, and the fluid leak was observed at the side of the console.The start-up kit (suk) (lot# unknown) was not replaced as the patient was treated conservatively without the thermogard console.No injury or adverse impact was reported.The patient is stable.

• 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: 18035623
• MDR Text Key: 327661366
• Report Number: 3010617000-2023-00924
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• 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
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• 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