MAUDE Adverse Event Report: AMBU AMBU #4 LARYNGEAL MASK AIRWAY

Lot Number 1599964

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2014

Event Type  malfunction  

Event Description

A 15mm connector discovered fractured at end of 2 hour surgical procedure, broken off piece of airway device not recovered, no patient harm.Diagnosis or reason for use: anesthesia for surgery.

• Brand Name: AMBU #4 LARYNGEAL MASK AIRWAY
• Type of Device: AMBU #4 LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): AMBU
• MDR Report Key: 3651186
• MDR Text Key: 4287321
• Report Number: MW5034730
• Device Sequence Number: 1
• Product Code: CAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2014

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: Health Professional
• Device Lot Number: 1599964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 73