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

Model Number 6-820-00

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 10/05/2020

Event Type  malfunction  

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 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
• Type of Device: INSUFFLATOR
• 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: 10802174
• MDR Text Key: 215533248
• Report Number: 0001450997-2020-00008
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 00817183020233
• UDI-Public: 00817183020233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6-820-00
• Device Catalogue Number: 6-820-00
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention