MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. In-Line Gas Warmer; CO2 GAS WARMING UNIT

Model Number	72-00204-0
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The warmer, nti part number 72-00204-0; serial number: (b)(4) arrived at nti on 06/05/2019 from us distributor smith and nephew, inc.The unit was evaluated under nti capa (b)(4).The warmer was received disassembled and the cable was completely separated from the warmer cartridge.There was evidence of a high temperature event noted (e.G., the red wire insulation appeared to be melted away and fused to the blue wire).The warmer cartridge was then further dissected and a void was observed in the epoxy-filled cartridge cavity.Additionally, at the lemo connector, the collet nut was not seated all the way into the connector housing.This was caused by a mis-alignment of the connector body inside the connector shell.The mis-alignment was confirmed by a continuity check between the open wires and the pins on the connector.The connector body was found to be rotated one pin off center in the.Counterclockwise direction.A mis-alignment of the connector could result in an uncontrolled current going to the warmer (refer capa (b)(4)) causing overheating.The root cause of the overheating was most likely due to the mis-alignment of the lemo connector when the connector was reassembled.The separation of the cable from the warmer cartridge could be contributed by inadequate lap solder joints within the warmer cartridge.The mis-alignment issue of the lemo connector and inadequate solder joint issue have been addressed in capa (b)(4), respectively.All requests for additional information and clarification from the end user went unanswered.A device history record review (dhr) was conducted for the warmer under complaint (b)(4).The device history record for (b)(4) from september of 2017 (mo (b)(4)) was reviewed and the device passed all testing.Nothing out of the ordinary was noted.There have been no other complaints reported to nti for this device.Any additional findings will be updated via a follow-up report.
Event or Problem Description
On 05/30/2019, northgate technologies was made aware of an issue with an in-line warmer from distributor (b)(4) in the usa where it was alleged, "it was reported that the device started heating up and the cable started smoking, then the control unit turned off.No patient injury or significant delay were reported.Back up device was available.".

• Brand Name: In-Line Gas Warmer
• Common Device Name: CO2 GAS WARMING UNIT
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 8744812
• Report Number: 0001450997-2019-00003
• Device Sequence Number: 2043518
• Product Code: HIF
• UDI-Device Identifier: 03596010500601
• UDI-Public: 03596010500601
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K972675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72-00204-0
• Device Catalogue Number: 7209944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1