MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED

Model Number 500-000-000-

Device Problems Electrical /Electronic Property Problem (1198); Human-Device Interface Problem (2949)

Patient Problem Injury (2348)

Event Date 08/06/2019

Event Type  malfunction  

Manufacturer Narrative

Title comparing the mcgrath mac video laryngoscope and direct laryngoscopy for prehospital emergency intubation in air rescue patients: a multicenter, randomized, controlled trial source critical care medicine, volume 20, 2019 (1-9) article number: 30.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between april 2017 and july 2018, video larygoscope and direct laryngoscopy were compared for the prehospital setting.It was reported that despite better visualization of the glottis with the video larygoscope, there were increased technical problems that significantly affected the advancement of the tube into the larynx or the trachea which were impaired sight due to fogged camera lens, monitor reflexes, ambient light.8 of 294 patients had tracheal injuries.There was one patient with a tooth injury and all other tracheal intubation injuries were superficial dermal or mucosal abrasions.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• MDR Report Key: 9160330
• MDR Text Key: 165609932
• Report Number: 3010244187-2019-00012
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 500-000-000-
• Device Catalogue Number: 500-000-000-
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other