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

Model Number	6-820-00
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The warmer, nti part number 6-820-00; serial number unknown, arrived at nti on (b)(6) 2020 from (b)(6) distributor amco, inc.The unit was evaluated under nti capa (b)(4).The serial number of the device involved in the complaint is unknown as the customer removed the serial tag from the product.The pin location for the id resistor was at the wrong location with respect to the connector orientation.Due to the incorrect orientation of the pins in the connector, the root cause of the over-heating was most likely due to misaligned pins on the connector assembly as a result of improper re-assembly or disengagement over time.A misaligned connector could cause an uncontrolled current to flow through the warmer resulting in overheating.The mis-alignment issue of the connector has been addressed in capa (b)(4).The collet nut is now secured to the connector using loctite during manufacturing as a preventive measure.Without the serial number tag, it is not possible to determine the possible length of time in the field nor number of uses.Any additional findings will be updated via a follow-up report.
Event or Problem Description
On (b)(6) 2020, northgate technologies was made aware of an issue with an in-line warmer from distributor amco in (b)(6) where it was alleged, "shortly after starting to use nebulae i and the warmer, the user noticed smoke was coming of the warmer and the warmer heated up to too high temperature without an alarm." the patient suffered a 2mm burn injury.

• Brand Name: NEBULAE I
• Common Device Name: INSUFFLATOR
• Manufacturer (Section D): NORTHGATE TECHNOLOGIES INC.; 1591 scottsdale court; elgin IL 60123
• MDR Report Key: 10802174
• Report Number: 0001450997-2020-00008
• Device Sequence Number: 1125609
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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: Health Professional
• Device Model Number: 6-820-00
• Device Catalogue Number: 6-820-00
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention