MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. NEBULAE I; INSUFFLATOR

Model Number	6-820-00
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The warmer, nti part number 6-820-00; serial number (b)(4) arrived at nti on 2/26/2019 from (b)(4).The unit was evaluated under nti capa (b)(4).The performance of the warmer was tested on two separate days and the warmer performed as expected.However, there was evidence of a high temperature event noted (e.G., there was evidence of melted plastic on the sheath and the warmer core could not be removed from the cap; when the warmer cap was separated from the warmer cartridge there was evidence of melting noted on the cap).The warmer cartridge was then further dissected and a void was observed in the epoxy-filled cartridge cavity.Additionally, the insulating jacket of the red conductor appears to be pulled back from the heat-shrink tubing exposing the bare wire.After removing more material from the cavity, the blue cable also showed exposed wire.Based on the investigation of capa (b)(4), shorting of the red and to blue wires will caused uncontrolled flow of current to the heater element.The root cause is likely due to shorting of the exposed red and blue which resulted from repeated pulling on the cable over time, coupled with thermal expansion during operation, in the area where the cables and leads are not fully encapsulated by epoxy.Upon follow-up communication with the distributor in (b)(4), it was determined that the warmer had been autoclaved approximately 100 times, which is the defined life of the warmer according to the product requirement specification document (b)(4).The insufflator unit used by the customer with the warmer in this incident was not returned for evaluation despite our request.A device history record review (dhr) was conducted for the warmer under complaint (b)(4).Warmer sn (b)(4) was manufactured under manufacturing order (b)(4).The unit passed final inspection after a 6-hour "burn-in" on 9/26/2017.Nothing out of the ordinary was noted.The thermistor, rtd1 measured 108.90 ohms.Any additional findings will be updated via a follow-up report.(b)(4).
Event or Problem Description
On 2/22/2019, northgate technologies was made aware of an issue with an in-line warmer from distributor (b)(4) where it was alleged, "five minutes passed after the gas warmer connected to the unit, smoke occurred from the connected part of the warmer and tubing.According to the user, he did not see the sign for over-temperature alert and did not hear the error sound emitted.The issue is not duplicative at our office but the gas could not flow through the gas warmer.(not duplicative at our office) (visible burn marks on the surface).".
Additional Manufacturer Narrative
It was identified after submission to the fda that the "additional manufacturer narrative" contained an inaccurate reference to an internal complaint number.The first sentence of the fourth paragraph indicates "a device history record review (dhr) was conducted for the warmer under complaint (b)(4)." the correct complaint number reference is complaint (b)(4).The warmer, nti part number 6-820-00; serial number (b)(4) arrived at nti on 2/26/2019 from (b)(4) distributor (b)(4).The unit was evaluated under nti capa (b)(4).The performance of the warmer was tested on two separate days and the warmer performed as expected.However, there was evidence of a high temperature event noted (e.G., there was evidence of melted plastic on the sheath and the warmer core could not be removed from the cap; when the warmer cap was separated from the warmer cartridge there was evidence of melting noted on the cap).The warmer cartridge was then further dissected and a void was observed in the epoxy-filled cartridge cavity.Additionally, the insulating jacket of the red conductor appears to be pulled back from the heat-shrink tubing exposing the bare wire.After removing more material from the cavity, the blue cable also showed exposed wire.Based on the investigation of capa (b)(4), shorting of the red and to blue wires will caused uncontrolled flow of current to the heater element.The root cause is likely due to shorting of the exposed red and blue which resulted from repeated pulling on the cable over time, coupled with thermal expansion during operation, in the area where the cables and leads are not fully encapsulated by epoxy.Upon follow-up communication with the distributor in japan, it was determined that the warmer had been autoclaved approximately 100 times, which is the defined life of the warmer according to the product requirement specification document (b)(4).The insufflator unit used by the customer with the warmer in this incident was not returned for evaluation despite our request.A device history record review (dhr) was conducted for the warmer under complaint (b)(4).Warmer sn (b)(4) was manufactured under manufacturing order (b)(4).The unit passed final inspection after a 6-hour "burn-in" on 9/26/2017.Nothing out of the ordinary was noted.The thermistor, rtd1 measured 108.90 ohms.Any additional findings will be updated via a follow-up report.

• Brand Name: NEBULAE I
• Common Device Name: INSUFFLATOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 8439732
• Report Number: 0001450997-2019-00002
• Device Sequence Number: 11494409
• Product Code: HIF
• UDI-Device Identifier: 00817183020233
• UDI-Public: 00817183020233
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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
• Operator of Device: No Information
• Device Model Number: 6-820-00
• Device Catalogue Number: 6-820-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 02/22/2019
• Supplement Date Received by Manufacturer: 02/22/2019
• Initial Report FDA Received Date: 03/21/2019
• Supplement Report FDA Received Date: 04/15/2019
• Patient Sequence Number: 1