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

Model Number	518541
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
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.
Event or Problem 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
• Common Device Name: AIRWAY, ESOPHAGEAL (OBTURATOR)
• MDR Report Key: 12032484
• Report Number: 8020889-2021-00059
• Device Sequence Number: 11730161
• Product Code: CAO
• UDI-Device Identifier: 20884521105574
• UDI-Public: 20884521105574
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K875226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 518541
• Device Catalogue Number: 518541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR