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

Model Number 8700-0650

Device Problem Device Issue (2379)

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

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, the thermogard console (b)(4) pump rotor was not rotating during run mode and was not able to prime the suk.Another console was used to treat the patient.No known impact or consequence to patient was reported.

Manufacturer Narrative

The report of the thermogard console (sn (b)(4) roller pump not spinning was during run mode was not reproduced during functional testing.Information received from a representative of the manufacturer's technical service team.The thermogard console (sn (b)(4) has no physical damage.The console was functionally tested and found no issue.Review of the event log indicated that the system was on standby on the controlled rate setting.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for the thermogard console with serial number (b)(4).Ccr (b)(4) reported on (b)(6) 2017.Biomed tighten the loose screw on the middle of the roller pump to remedy the issue.

• Brand Name: ZOLL IVTM THERMOGARD XP
• Type of Device: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7625807
• MDR Text Key: 111904377
• Report Number: 3010617000-2018-00658
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (y/n): N
• PMA/PMN Number: K072234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1