MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED MCGRATH; LARYNGOSCOPE, RIGID

Model Number 300-000-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 01/24/2017

Event Type  Death  

Manufacturer Narrative

Title: video laryngoscopy vs direct laryngoscopy on successful first-pass orotracheal intubation among icu patients source: jean baptiste lascarrou, md, 2017, journal of the american medical association.If information is provided in the future, a supplemental report will be issued.

Event Description

Pli 20: according to literature source of study performed between may 2015 and january 2016, the device was used to determine if routine use for orotracheal intubation of patients in the icu increased the frequency of successful first-pass intubation compared with use of the (b)(6) direct laryngoscope.Out of 186 patients in the group, there was one patient death.All but 2 patients were intubated.It was unclear whether all complications were directly related to the device or due to patient status at the time of intubation/other comorbidities.

• Brand Name: MCGRATH
• Type of Device: LARYNGOSCOPE, RIGID
• 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: 9179250
• MDR Text Key: 161966150
• Report Number: 3010244187-2019-00015
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300-000-000
• Device Catalogue Number: 300-000-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention