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

Model Number 8700-0650

Device Problems Insufficient Heating (1287); Temperature Problem (3022)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During ivtm therapy, the customer reported that the thermogard ivtm system (sn (b)(4)) temperature was not steadily rewarming the patient.The customer changed the temperature probe but it did not resolve the temperature issue.Another thermogard console was used to continue with treatment.No consequences or impact to the patient.

Manufacturer Narrative

The customer reported that the thermogard ivtm system (sn (b)(6) temperature was not steadily in rewarming the patient was confirmed during patient event log review.Based on the patient event log, there are multiple "negative strike" in the patient temperature during the rewarming phase.The negative spike phenomena occured when the patient was infused with liquid during the rewarming phase.The thermogard ivtm system algorithm software delayed the rewarming process after the sudden drop of the patient temperature had occurred.Issue can be avoided by placing the thermogard ivtm system in standby mode during liquid infusion or flushing (esophageal, bladder or abdominal) on patient and place back to run mode when the patient temperature is normalized.Therefore, the root cause of the reported complaint was due to user error.The customer has been notified for re-training.During visual inspection, no physical damage was observed on the thermogard console.During event log review, no descrepancies/hardware error was observed.During patient event log, observed multiple "negative strike" in the patient temperature during the rewarming phase therapy.During functional testing, the thermogard xp ivtm system passed the final testing without any error.There was no malfunction and the console performed as intended.

• 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: 12764049
• MDR Text Key: 280464405
• Report Number: 3010617000-2021-01047
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2019
• 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