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

Model Number 8700-0650

Device Problem Insufficient Cooling (1130)

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

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint of the thermogard console (sn (b)(4) not cooling was confirmed during the functional testing and event log review.The root cause of the observed console issue was due to a defective pic-16 circuit board as a result of wear and tear.The thermogard console is a reusable device that was manufactured in october 2014 and is more than 8 years old, well beyond its expected serviceable life of 5 years.During visual inspection, no physical damage was observed on the thermogard console.During the event log review, no significant discrepancy was identified, however, the review of the patient event log confirmed not sufficient cooling.The thermogard console failed the initial functional testing as it could not cool, thus confirming the reported complaint.The pic-16 circuit board needs to be replaced to remedy the issue.Waiting for the customer's approval for service repair.Also, the customer was offered to purchase a new console.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)(4).

Event Description

During a periodic inspection performed by a zoll technician at the customer site, the thermogard console (sn (b)(4) would not cool.The warming is functioning correctly.No patient involvement.

• 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: 16700002
• MDR Text Key: 312864499
• Report Number: 3010617000-2023-00330
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2023
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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