MAUDE Adverse Event Report: NORTHGATE TECHNOLOGIES INC. 50L ABDOMINAL INSUFFLATOR; INSUFLATOR

Catalog Number GS2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Sudden Cardiac Death (2510)

Event Date 12/06/2018

Event Type  Death  

Manufacturer Narrative

Voluntary distributor report.The manufacturer northgate technologies is responsible for performing evaluation, investigation and remedial actions related to this reported device issue per agreement with (b)(4).The service history was reviewed, and no data was found.The device history record could not be reviewed, as this device is not manufactured by (b)(4).A two-year review of complaint history revealed there have been 5 complaints, regarding 5 devices for this device family and failure mode.During the same time frame there has been (b)(4) devices manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure the rate of failure would be (b)(4).This issue will continue to be monitored through the complaint system to assure patient safety.Per the instructions for use, the user is advised the following during use in bariatric mode: always monitor the patient's respiratory functions during the entire surgery.When puncturing the thicker abdominal wall of morbidly obese patients with the verres needle or the trocar, carefully monitor the correct position of the instrument in the abdomen.Constantly monitor all heart and cardiovascular parameters during surgery since morbidly obese patients have an increased risk of heart and cardiovascular insufficiencies.

Event Description

Voluntary distributor report.The customer reported that the gs2000 insuflator was involved in a case with a death.The procedure was a bariatric surgery on (b)(6) 2018.The customer asked the (b)(4) "represetative" to come and inspect the machine to be sure it was functioning as expected.The device was only named due to the fact it was in the room.The biomed dept does not feel this was in any way the cause or contributing to the death.Additional information was provided to us by the customer via a conference call and was passed along to the oem, northgate technologies.They have evaluation and reporting responsibility.The device was sent to them on 12/11/2018 for evaluation.Additional information was received from northgate, the evaluation was completed 12/27/2018, there was no fault found with the "functionaliity", the safety pressures or safety measures.Based on this information northgate will not be filing to the fda, per cfr 803.50.This report is being raised due to the death of a patient.

• Brand Name: 50L ABDOMINAL INSUFFLATOR
• Type of Device: INSUFLATOR
• 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: melanie hansen ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 8209824
• MDR Text Key: 131848904
• Report Number: 1017294-2018-00187
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GS2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 136