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

Model Number 8700-0650

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The thermogard in the complaint was evaluated at customer's site.The customer reported complaint of the thermogard console alarmed and stopped and displayed "pump lid" error message was confirmed during the functional testing and archive review.The issue was attributed to a damaged pump raceway caused by corrosion on the raceway board.The raceway unit was replaced to remedy the issue.Once completed, the thermogard passed the functional testing with no issue or faults observed.Archive log was review confirmed that the raceway was not functioned properly.The biomed replaced the raceway and placed the system back into service.The customer will retain all service records historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for thermogard with serial number (b)(4).

Event Description

During ivtm cooling therapy for a patient with neuro fever, the thermogard console began alarming and stopped with "pump lid" alert on the display.Customer noted the lid was fully latched.The user tried to power on and off the console, however, was unsuccessful.The customer was directed by zoll tech line employee to follow troubleshooting steps, however, "pump lid" alert was not cleared.Another thermogard console was used to continue the treatment.No patient harm or consequence was reported.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 7636487
• MDR Text Key: 112312744
• Report Number: 3010617000-2018-00665
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2015
• 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