MAUDE Adverse Event Report: BESMED HEALTH BUSINESS CORPORATION AMBU AURASTRAIGHT SILICONE; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Model Number 342300000, 342500000, 342400000

Device Problem Difficult to Insert (1316)

Patient Problem No Code Available (3191)

Event Date 09/27/2019

Event Type  malfunction  

Event Description

Anesthesiologist attempted to place laryngeal mask airway (lma) x3 (ambu aurastraight silicone single use laryngeal mask) with difficulty and without success.Lma of various sizes would not go down or stay in the proper place.Patient had moderate bloody secretions.Anesthesia's plan for general anesthesia converted to monitored anesthesia care.Mac sedation used for procedure instead of planned general anesthesia.

• Brand Name: AMBU AURASTRAIGHT SILICONE
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): BESMED HEALTH BUSINESS CORPORATION; 13729 shadow ridge; chino hills CA 91709
• MDR Report Key: 9314545
• MDR Text Key: 166180932
• Report Number: 9314545
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/05/2019,10/15/2019

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
• Device Operator: No Information
• Device Model Number: 342300000, 342500000, 342400000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2019
• Date Report to Manufacturer: 11/13/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA