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 03/07/2024

Event Type  malfunction  

Manufacturer Narrative

The thermogard console in the complaint was returned to zoll on (b)(6) 2024 for evaluation.However, the investigation is still in progress.A supplemental report will be filed when the investigation has been completed.

Event Description

During ivtm therapy, the thermogard xp ivtm system sn (b)(6) frequently displayed tcmid:(b)(4).(ce danfoss error) error messages.Another thermogard console was used to continue the treatment.No patient injury was reported.

Manufacturer Narrative

H4 (device manufacture date) was updated.The customer's reported complaint that the thermogard xp ivtm system (sn (b)(6)) frequently displayed tcmid:02 (ce danfoss error) error messages was confirmed in the system's event log data and during functional testing.The root cause was a degraded cable connection between the danfoss module and pic 16 board due to burnt pins on the connectors, likely due to corrosion and electrical shorting inside the connectors.The thermogard console was manufactured in october 2015 and is over 8 years old, well beyond its expected service life of 5 years.No physical damage was observed on the thermogard console during the visual inspection.Reviewing the system's event log data showed tcmid:02 (ce danfoss error) error messages around the reported event date, confirming the reported complaint.The system failed initial functional testing due to a tcmid:02 error message, confirming the reported complaint.The investigation findings revealed burned pins on the p22 connector of the pic-hsg cable harness and the j22 connector on the cooling engine harness, which connects the danfoss module to the pic 16 board.The assembly wire harness pic 16 was replaced to remedy the issue.The pic16 board and the danfoss module controller were replaced as a precautionary measure to prevent the reoccurrence of a possible connection issue between the two connectors.Following service, the thermogard console passed all 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 complaints reported for the thermogard console with serial number (b)(6).

• 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 sackrison ; 2000 ringwood ave.; san jose 95131 ; 4084192922
• MDR Report Key: 18984273
• MDR Text Key: 338674254
• Report Number: 3010617000-2024-00279
• 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: 05/03/2024

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: 03/23/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/14/2024
• Supplement Dates FDA Received: 05/03/2024
• 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