MAUDE Adverse Event Report: MALLINCKRODT MEDICAL MALLINCKRODT; AIRWAY, ESOPHAGEAL (OBTURATOR)

Model Number 518541

Device Problem Human-Device Interface Problem (2949)

Patient Problem Airway Obstruction (1699)

Event Date 10/05/2020

Event Type  Injury  

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.

Event Description

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.

• Brand Name: MALLINCKRODT
• Type of Device: AIRWAY, ESOPHAGEAL (OBTURATOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810 ; EI 3810
• MDR Report Key: 12032484
• MDR Text Key: 257390769
• Report Number: 8020889-2021-00059
• Device Sequence Number: 1
• Product Code: CAO
• UDI-Device Identifier: 20884521105574
• UDI-Public: 20884521105574
• Combination Product (y/n): N
• PMA/PMN Number: K875226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial
• Report Date: 06/21/2021

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: 518541
• Device Catalogue Number: 518541
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/21/2021
• 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): Required Intervention
• Patient Age: 47 YR