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	Burn, Thermal (2530)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
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).There was evidence of a high temperature event noted (a charred smell was noted from the unit after the sheath was removed, the heater element was discolored, the warmer cartridge was fused to the warmer cap, after the cartridge was removed the cap had evidence of melting due to overheating of the core).A kink was noted on the cable, and when the cable was flexed around the kink (pushing the cable in) while the warmer was plugged into a warmer board using a bench power supply, the current would intermittently jump to 1.2a.Further measurement on the connector showed that pin 4 (heater element return) would short to pin 1 (gnd) when the above condition happens - this would result in an unlimited current flow to the warmer causing overheating.The root cause was identified as excessive bending and stress on the cable causing internal cable insulations to deteriorate and exposing the bare wires.Shorting of the bare wires (i.E.Heater element return wire to the ground return of the rtd) resulted in unlimited current flow to the heater element.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 8/9/2017.During the initial final testing of this unit, epoxy was noted on the heater body that required additional cleaning before final testing was completed.The device passed all testing after the heater body was cleaned.The thermistor, rtd1 measured 108.51 ohms.Any additional findings will be updated via a follow-up report.(b)(4).
Event or Problem Description
On (b)(6) 2019, northgate technologies was made aware of an issue with an in-line warmer from distributor (b)(4) where it was alleged, "the alarm of overheating of the gas warmer emitted and the patient got 3 degree burn on the surface of the skin near a navel.".

• Brand Name: NEBULAE I
• Common Device Name: INSUFFLATOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 8416203
• Report Number: 0001450997-2019-00001
• Device Sequence Number: 1612445
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/13/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERAL USE TUBING SET; INSUFFLATOR; TROCAR
• Outcome Attributed to Adverse Event: Other