FDA Adverse Event Injury Summary report: N

MCGRATH

MDR report key: 9180543 · Received October 11, 2019

Report

Report Number
3010244187-2019-00017
Event Type
Injury
Date Received
October 11, 2019
Date of Event
July 7, 2017
Report Date
October 11, 2019
Manufacturer
AIRCRAFT MEDICAL LIMITED
Product Code
CCW
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
IN
Reporter Occupation
003

Narratives

Additional Manufacturer Narrative · 1

(B)(4). TITLE A COMPARATIVE STUDY OF MCGRATH AND AIRTRAQ VIDEOLARYNGOSCOPES FOR TRACHEAL INTUBATION SOURCE JOURNAL OF ANAESTHESIOLOGY CLINICAL PHARMACOLOGY, VOLUME 33, 2017 (221-225) ARTICLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

ACCORDING TO THE LITERATURE, THE STUDY WAS DESIGNED TO COMPARE THE PERFORMANCE OF TWO UNITS. THERE WAS THREE CASES WITH BLOOD ON THE LARYNGOSCOPE BLADE, THERE WAS AN INCREASE IN HEART RATE AND MEAN ARTERIAL BLOOD PRESSURE AFTER TRACHEAL INTUBATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
974144 MCGRATH LARYNGOSCOPE, RIGID CCW AIRCRAFT MEDICAL LIMITED 300-000-000

Patients

Seq Age Sex Outcome Treatment
1 32 YR Other