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 03/16/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the thermogard xp ivtm system (b)(6) displayed tcmid:02 (ce danfoss error) error message was confirmed based on the event log review and during functional testing.The possible root cause of the reported issue was a failure of the danfoss module, likely attributed to an aging device.The console was manufactured in 2015 and is 9 years old, well past the expected service life of 5 years.Upon visual inspection, no physical damage was observed.Event log data review was performed and showed tcmid:02 (ce danfoss error) error message, thus confirming the reported complaint.The console failed functional testing due to the displayed tcmid:02 error message, thus confirming the reported complaint.The danfoss electronic controller module and its pcb, pic16 wire harness, and cooling engine wire harness were replaced to remedy the fault.Following service, the thermogard console passed all subsequent functional and electrical tests with no issues, and readings were within the specified limits.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for thermogard ivtm system with (b)(6).

Event Description

During functional testing by the medical department at the customer site, the thermogard xp ivtm system (b)(6) displayed tcmid:02 (ce danfoss error) error message.No patient involvement.

• 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: 19042807
• MDR Text Key: 339550035
• Report Number: 3010617000-2024-00292
• 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: 04/04/2024

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: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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