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

Catalog Number 324 300 000 U

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 07/10/2018

Event Type  malfunction  

Event Description

Patient to undergo breast needle localized partial mastectomy.Patient was placed under general anesthesia via lma (laryngeal mask airway).However, patient had to be intubated during procedure since lma slipped in mouth (not protecting airway).

• Brand Name: AMBU AURASTRAIGHT
• Type of Device: AIRWAY, OROPHARYNGEAL
• Manufacturer (Section D): AMBU, INC.; 6230 old dobbin ln ste 250; columbia MD 21045
• MDR Report Key: 7742410
• MDR Text Key: 115834299
• Report Number: 7742410
• 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?: No
• 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: 18615 DA
• Patient Weight: 66