MALLINCKRODT
Received Jun 21, 2021 · Event occurred Oct 5, 2020
Report 8020889-2021-00059 · MDR key 12032484
Device
Product problems
- Human-Device Interface Problem
- Human-Device Interface Problem
Patient
47 YR
- Airway Obstruction
- Airway Obstruction
Narrative
Additional Manufacturer Narrative
TITLE: EXTRAGLOTTIC AIRWAY DEVICE MISPLACEMENT: A NOVEL CLASSIFICATION SYSTEM AND FINDINGS IN POSTMORTEM COMPUTED TOMOGRAPHY SOURCE: 2020 BY THE AMERICAN COLLEGE OF EMERGENCY PHYSICIANS. HTTPS://DOI.ORG/10.1016/J.ANNEMERGMED.2020.10.005. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE LITERATURE SOURCE OF STUDY, A SYSTEMATICALLY REVIEWED POSTMORTEM CT WAS TO IDENTIFY AND CLASSIFY EXTRAGLOTTIC AIRWAY DEVICE MISPLACEMENT. THE CLASSIFICATION SYSTEM CONSISTED OF 6 COMPONENTS: DEPTH, SIZE, ROTATION, DEVICE KINKING, MECHANICAL BLOCKAGE OF VENTILATION OPENING, AND INJURY. THE RETROGLOTTIC AIRWAY DEVICES HAD 2 BALLOONS, ONE SEALING OFF THE PHARYNX AND THE OTHER SEALING OFF THE ESOPHAGUS, WITH VENTILATION INTO THE AIRWAY OCCURRING FROM HOLES BETWEEN THE 2 BALLOONS, WHILE THE ESOPHAGEAL-TRACHEAL COMBITUBE DIFFERED FROM OTHER RETROGLOTTIC AIRWAY DEVICES AS IT HAD DUAL LUMENS AND PROVIDE VENTILATION WHETHER THE DEVICE SITS IN THE ESOPHAGUS OR TRACHEA. UNDER THE SYSTEM, EXTRAGLOTTIC AIRWAY DEVICES WERE FOUND TO BE MISPLACED IN 49 CASES (14.4%), INCLUDING 5 (1.5%) THAT RESULTED IN SEVERE INJURIES.