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

Model Number 8700-0650

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 03/01/2024

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

On mar.1, when turned on for patient use, the thermogard xp ivtm system (sn (b)(6)displayed a tcmid : (b)(4).(coolant temp high) error message.The customer rebooted the console several times, but the issue remained unresolved.No patient involvement.

Manufacturer Narrative

The customer's reported complaint that the thermogard xp ivtm system (sn (b)(6) ) displayed a tcmid:07 (coolant temp high) error message was confirmed during the review of the event logs but was not confirmed during functional testing.The reported issue was not replicated during testing, and the thermogard ivtm system functioned as intended.During visual inspection of the thermogard console, no physical damage was observed.During the review of the event logs, tcmid:07 error message was observed; thus, confirming the reported complaint.The thermogard xp ivtm system passed functional testing including the power-on-self-test (post) with no issues.The customer's complaint was not reproduced.Upon service completion, the console will be subjected to final functional testing to ensure that the device passes all testing criteria.

• 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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18988115
• MDR Text Key: 338750200
• Report Number: 3010617000-2024-00253
• 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: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 03/24/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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