MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. NORTHGATE TECHNOLOGIES; IN-LINE GAS WARMER

Model Number 6-820-0

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4), investigated under capa (b)(4).The warmer serial (b)(4) was manufactured on 10/24/2016.Production history review determined the unit was run for 6-hours (initial burn-in), on 10/24/2017, and passed final qc inspection on 10/25/2016 under manufacturing order (mo (b)(4)).No discrepancies or deviations were noted in the device history for this lot of in-line warmers.The warmer from (b)(4) was shipped on 11/20/2017 and was received on 11/27/2017.The warmer was evaluated by engineering.The warmer was received with tubing connected which was discolored - it is unknown if this was due to a thermal event.The id resistor (in the connector) was not reading; however the resistive thermal device (rtd) and warmer appeared to be functioning nominally.The id resistor in the connector not reading would be consistent with the report from the distributor that "the connecting parts of the in-line warmer was damaged, when they removed the product from the socket." it is believed this may be caused by customer mis-use.The insufflator was requested, but nti was informed that the insufflator unit (nebulae i) was returned to the customer and will not be returned to nti for evaluation.Based upon the assessment of the warmer, a root cause cannot be determined at this time without the insufflator unit.Unrelated to these events, the in-line warmer, pn 6-820-00 has been undergoing validation for a required part change (due to obsolescence of the warming element, and integration of udi labels).The validation is a simulated use test.No adverse effects have been noted during the validation.

Event Description

Northgate technologies incorporated was notified via e-mail on (b)(6) 2017 by customer (b)(4) (distributor in (b)(4)) in it was alleged: "the customer found that smoke occurred from the part of in-line warmer soon after they connect the warmer to the unit.As a result, the part of the warmer was burnt.2) also, they found the connecting parts of the in-line warmer was damaged, when they removed the product from the socket.".

• Brand Name: NORTHGATE TECHNOLOGIES
• Type of Device: IN-LINE GAS WARMER
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer (Section G): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• Manufacturer Contact: todd gatto ; 1591 scottsdale court; elgin, IL 60123 ; 2248562250
• MDR Report Key: 7831444
• MDR Text Key: 118896438
• Report Number: 0001450997-2018-00001
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 00817183020233
• UDI-Public: 00817183020233
• Combination Product (y/n): N
• PMA/PMN Number: K992381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 01/11/2018

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: No Information
• Device Model Number: 6-820-0
• Device Catalogue Number: 6-820-0
• Device Lot Number: 12445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• 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