MAUDE Adverse Event Report: AMBU, INC. AMBU AURASTRAIGHT; AIRWAY, OROPHARANGEAL

Catalog Number 324 300 000 U

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 07/03/2018

Event Type  malfunction  

Event Description

A patient was scheduled to have a circumcision with excision of the inclusion cyst.General anesthesia through lma (laryngeal mask airway) was done.Anesthesia concern: new green lma not "seating" correctly; airway not protected adequately and therefore a patient safety issue.

• Brand Name: AMBU AURASTRAIGHT
• Type of Device: AIRWAY, OROPHARANGEAL
• Manufacturer (Section D): AMBU, INC.; 6230 old dobbin ln ste 250; columbia MD 21045
• MDR Report Key: 7742400
• MDR Text Key: 115834177
• Report Number: 7742400
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 324 300 000 U
• Device Lot Number: 1000054203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA
• Patient Weight: 76