MAUDE Adverse Event Report: AMBU A/S AURAFLEX; LAYRNGEAL MASK

Catalog Number 327300000

Device Problem Leak/Splash (1354)

Patient Problem Hypoxia (1918)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Ambu has become aware of 5 cases of hypoxia arising during the use of auraflex.All five cases occured on the same children's hospital in (b)(6).The customer complained that the material of the auraflex tube is too hard compared with competitor devices, and that this causes the laryngeal mask to move backwards causing air leakage and poor ventilation.No sample or pictures were available for investigation.The hardness of the auraflex tube is designed to ensure that the tube does not kink or compress and to make handling and insertion of the tube easier.Per the customer complaint the air leakage happened because the auraflex moved backwards, when the doctor released their hands after inserting the tube.It is required in the auraflex instruction for use to fixate the device to the patient face in case of any movement.This is the first complaint on auraflex related to desaturation of a patient.

Event Description

Customer complained that the catheter material of the auraflex is too hard compared to competitor devices.This causes the larynx mask to move backwards after releasing the hands causing air leakage and poor ventilation.This has resulted in hypoxia in 5 children.

• Brand Name: AURAFLEX
• Type of Device: LAYRNGEAL MASK
• Manufacturer (Section D): AMBU A/S; baltorpbakken13; ballerup, 2750 ; DA 2750
• Manufacturer (Section G): AMBU A/S; baltorpbakken 13; ballerup, 2750 ; DA 2750
• Manufacturer Contact: nina skjoldborg ; baltorpbakken 13; ballerup, 2750 ; DA 2750
• MDR Report Key: 11243429
• MDR Text Key: 243739280
• Report Number: 9610691-2021-00003
• 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: health professional
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 327300000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention