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

Model Number 6-820-00

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

The warmer, nti part number 6-820-00; serial number (b)(4) arrived at nti on 1/30/2020 from (b)(4) distributor (b)(4).The unit was evaluated under nti capa (b)(4).During engineering inspection, the warmer was found to have experienced high heat as evidenced by the inside of housing fused together with the core.The backnutnut of the connecter was found to not be fully engaged onto the housing.The connector pins were found to be indexed one position axially, which, per capa (b)(4) (closed october 2018), causes the warmer to overheat and not display on-screen and no audible alert.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 root cause is that connector was indexed in such a way which resulted in the device not showing the warmer icon and overheating with no audible alert.This root cause was identified in capa (b)(4) and corrective actions were taken on all product manufactured after closure of capa.The overtemperature event was not identified by the end user and was identified in a lab setting by the distributor.The device history record for (b)(4) from september of 2017 (manufacturing order (b)(4)) was reviewed and the device passed all testing.Nothing out of the ordinary was noted.The device has not been returned to nti for repair / evaluation previously.There have been no other complaints reported to nti for this device.(b)(4).

Event Description

On 1/17/2020, northgate technologies was made aware of an issue with an in-line warmer from distributor (b)(4) in (b)(4) where it was alleged, "our customer couldn't use the product and asked us to check it.During our inspection, even though the warmer connected to nebulae i, the unit didn't display any thermometer symbol.And after that, the warmer heated and smoked with no alarm.No adverse event and no delayed procedure.".

• 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: 9708950
• MDR Text Key: 179372827
• Report Number: 0001450997-2020-00004
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1