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 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the thermogard xp ivtm system for investigation.A follow-up report will be submitted when the investigation has been completed.

Event Description

During the warming phase of the ivtm therapy using the thermogard xp ivtm system (sn (b)(6), the customer observed that the coolant temperature didn't go up, and the patient's temperature didn't, either.No further information was provided, and no patient injury was reported.

Manufacturer Narrative

The customer's complaint that the coolant temperature didn't go up and the patient's temperature didn't, either during the ivtm therapy using the thermogard xp ivtm system (sn tgxp12113) was not confirmed during the functional testing and the event log review.The customer's complaint was not reproduced during the testing, and no cooling or heating problems were observed throughout the testing at zoll.Upon visual inspection, no physical damage was observed.The event log review indicated mid:14 (bg power supply) and mid:16 (software) errors around the reported event date.The observed errors are unrelated to the reported complaint.The thermogard system powered up with no issues during the functional testing, and the reported complaint was not reproduced.Upon further testing, unrelated to the reported complaint, the thermogard system displayed mid:16.The error was cleared upon erasing the patient data.Per the tgxp user manual, if a mid:16 error occurs during the treatment, this indicates that the treatment file memory is full.The console stops treatment.To continue treatment, power the console off and on.Follow the prompts and select current settings.When the data download information appears, immediately either delete the data or use temptrend to download the data and delete it.You may then resume treatment.The thermogard system was further subjected to extensive testing, and no issues were noted.The mid:14 error observed in the archive was not reproduced throughout the testing.The mid:14 error is related to the system ac/dc power supply.No such device malfunction was observed that could result in the mid:14 error.The thermogard system functioned as intended.Following service, the thermogard xp ivtm system passed the final functional, calibration, and electrical safety tests without issues.

• 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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18193338
• MDR Text Key: 328817599
• Report Number: 3010617000-2023-00987
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• 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: 11/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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