MAUDE Adverse Event Report: AMBU A/S AMBU AURASTRAIGHT; LARYNGEAL MASK

Catalog Number 324100000U

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/26/2016

Event Type  Injury  

Manufacturer Narrative

According to the instruction for use, the user must perform a visual inspection of the product and also do an inflation/deflation test prior to use.These instructions on inspection and test cannot be followed properly without removing the cuff protector.The event is evaluated as an user error.User did not remove the cuff protector.As part of the complaint investigation, the product risk evaluation has been reviewed.The reported problem is included in the risk analysis and the risk for a hazardous situation to occur as a result of the reported is concluded to be acceptable low.Device not returned.

Event Description

New born with respiratory failure day (b)(6) of life.A lma was used for a short time to ventilate patient.The lma was removed.Patient continued to have respiratory problems.On day (b)(6), a foreign body was found in the patient's oropharynx.Foreign body found to be the cuff protector of the lma.

• Brand Name: AMBU AURASTRAIGHT
• Type of Device: LARYNGEAL MASK
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, DK-27 50; DA DK-2750
• Manufacturer (Section G): AMBU INC; 6230 old dobbin lane; suite 250; columbia MD 21045
• Manufacturer Contact: sanjay parikh ; 6230 old dobbin lane; suite 250; columbia, MD 21045 ; 4107686464
• MDR Report Key: 5922503
• MDR Text Key: 53757565
• Report Number: 9610691-2016-00003
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• PMA/PMN Number: E221696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 324100000U
• Device Lot Number: 1689216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 DA