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

Model Number 8700-0650

Device Problems Device Issue (2379); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the thermogard console sn (b)(4) displaying "factory configuration not complete" error message upon power up was confirmed during functional testing and in the event log.Upon visual inspection the side panel of the console was dented and front housing cover is damage.These observation are not related to the reported event.Evaluation of the console revealed "factory configuration not complete" error message during initial power up.The cause of the error message was attributed to a defective input/output printed circuit board.The analysis of the event log revealed multiple mid27-3 (read cycle timeout) error messages and one mid27-4 (eeprom crc failure) on the reported event date.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for the thermogard console with serial number (b)(4).

Event Description

During setup of the themogard console sn (b)(4) displayed " factory configuration not complete error" error message on the display panel screen upon all power-ups.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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7652993
• MDR Text Key: 112858640
• Report Number: 3010617000-2018-00695
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2018
• 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