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

Model Number 8700-0650

Device Problems Insufficient Heating (1287); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 05/21/2021

Event Type  malfunction  

Manufacturer Narrative

An onsite evaluation of the thermogard console (sn (b)(4)) was performed by a zoll service technician.The customer reported complaint for the thermogard console intermittently warming was confirmed during functional testing but not during the event log review.The root cause for the reported complaint, was found out to be due to degraded and burnt contacts on the cooling engine (ce) connection wiring and the pic16 connection wiring to the pc board, that could have caused the thermogard console to intermittently warming.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.The cooling engine (ce) and the pic16 connection wiring were replaced to address the issue.The secondary reported complaint the pump did not turn during the treatment was confirmed during the visual inspection.The root cause for the reported complaint was the damaged pump rotor head handle.The probable cause could be due to the user mishandling.The pump rotor head was replaced to address the issue.Visual inspection was performed and noted missing pan drip.The observed issue is unrelated to the reported complaint.The probable cause could be due to the user mishandling.The missing pan drip was installed to address the issue.The event log review showed no significant discrepancies.Following service, the thermogard xp ivtm system passed the final testing without any error.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)(4).

Event Description

As reported, the thermogard console (sn (b)(4)) was intermittently warming and the pump did not turn during the treatment.No additional information was provided.The patient's status information was requested but the customer did not provide a response, therefore the patient's status is unknown.

• 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: 12007053
• MDR Text Key: 256531815
• Report Number: 3010617000-2021-00511
• 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: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• 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: 05/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• 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