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 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the product for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

On (b)(6) 2018, azm (b)(6) sale representative reported that during console demonstration, the thermogard xp ivtm system displayed a mid:14 (bg power supply) message after running for approximately 30 minutes.There was no patient involvement.

Manufacturer Narrative

The reported complaint of mid:14 (bg power supply) error message was not confirmed during function test and during review of event log file on the thermogard xp ivtm system (sn (b)(4)).No physical damage observed on the console during visual inspection.The console passed all functional tests without any issue and it is ready for therapy use.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for thermogard console serial number (b)(4).

• 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: 7626202
• MDR Text Key: 112057606
• Report Number: 3010617000-2018-00651
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2012
• 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