MAUDE Adverse Event Report: SOMMETRICS AERFREE AIRWAY MANAGEMENT SYSTEM (AMS); EXTERNAL AIRWAY

Model Number	30-5001
Health Effect - Clinical Code	Blister (4537)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
An airway positioning device, aerfree airway management system (ams), was applied to the pt's neck and then connected to suction.At end of procedure, the device was removed, and blisters were noted at the site.

• Brand Name: AERFREE AIRWAY MANAGEMENT SYSTEM (AMS)
• Common Device Name: EXTERNAL AIRWAY
• Manufacturer (Section D): SOMMETRICS; 2384 la mirada avenue; vista CA 92081
• MDR Report Key: 10634730
• Report Number: 10634730
• Device Sequence Number: 19127256
• Product Code: PMB
• UDI-Device Identifier: 00851167007001
• UDI-Public: (01)00851167007001(10)120426(1)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/21/2020
• Report Date (Section F): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 30-5001
• Device Catalogue Number: 30-5001
• Device Lot Number: 120426(1)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 136
• Date Report Sent to FDA: 09/23/2020