MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED

Model Number 500-000-000-

Device Problem Component Incompatible (1108)

Patient Problem No Information (3190)

Event Date 11/11/2018

Event Type  Injury  

Manufacturer Narrative

Title a comparison of the macintosh laryngoscope, mcgrath video laryngoscope, and pentax airway scope in paediatric nasotracheal intubation source scientific reports, volume 8, 2018 (1 - 7) date of publication: 26 november 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, the device failed to intubate the patient during procedure.It was reported that during advancement of the tube into the trachea after alignment with the glottic inlet, the reinforced tube often encountered resistance.It was stated that the use of forceps were required for advancing the tube and another device was used for intubation.The patient outcome was unknown.

• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer (Section G): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8217692
• MDR Text Key: 132205219
• Report Number: 3010244187-2019-00001
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 01/04/2019
• 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): Required Intervention