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

Model Number 8700-0650

Device Problem Insufficient Cooling (1130)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported a complaint that "the thermogard ivtm system sn (b)(4) cabel measured incorrectly, it's not cooling and makes loud noise" which was not confirmed during the event log review and during the functional testing.However, a wrong cable used on the thermogard ivtm system was observed.A monitor cable was connected instead of a patient cable which caused to show incorrect temperature measurement, likely attributed to user error.Unrelated to the reported complaint, worn-out guide rollers on the pump rotor were noted upon visual inspection.The observed cosmetic damages root cause is likely normal wear and tear.The thermogard xp ivtm system was manufactured in (b)(6) 2014 and is 9 years old, past beyond its service life of 5 years.The white guide rollers were replaced to address the observed cosmetic damage.The event log review indicated no discrepancy.The thermogard system passed the functional testing without errors.Following service, the thermogard xp ivtm system passed the final functional without any issues.

Event Description

The thermogard ivtm system sn (b)(4) cabel measured incorrectly, it's not cooling and makes loud noise.It is unknown where the problem occurred.However, patient use information was requested, but no additional information was provided.

• 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: 16968774
• MDR Text Key: 315907947
• Report Number: 3010617000-2023-00464
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2014
• 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