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

Model Number 8700-0650

Device Problem Insufficient Heating (1287)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the thermogard console for investigation.A follow-up report will be submitted when the console is returned and investigation has been completed.

Event Description

During testing, the tp400 patient temperature simulator was connected to the t1 input of the thermogard console (sn (b)(4)).The patient temperature was set to 32° celsius and the target temperature was set to 36° celsius.During the run mode, the console coldwell did not heat up as expected.There were no error messages or alarms displayed on the console.No patient involvement.

Manufacturer Narrative

The thermogard console (sn (b)(6) was evaluated at the customer site.The customer reported complaint of the thermogard console did not heat up as expected was confirmed during the functional testing.The root cause of the observed console issue was due to a defective cooling engine as a result of wear and tear.The thermogard console is a reusable device and was manufactured in february 2011 and is more than 10 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.The console failed the functional test, it was determined that the cooling compressor does not stop or switch off during the heating phase due to the defective cooling engine as a result, the heater could not heat the coolant sufficiently, thus confirming the customer complaint.The cooling engine needs to be replaced to address the issue.Waiting for customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for the thermogard console 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
• MDR Report Key: 12286290
• MDR Text Key: 265348388
• Report Number: 3010617000-2021-00731
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (y/n): N
• PMA/PMN Number: K072234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• 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: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1