MAUDE Adverse Event Report: BESMED HEALTH BUSINESS CORPORATION AURA 40 REUSABLE; LARYNGEAL MASK

Catalog Number 340400000

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

Supplier implemented 100% inspection in reference to trimming.Manufacture instruction for use for functional testing prior to device use was not followed by the user.This mdr is resubmitted again as it was identified that original submission had not been successfully loaded into the fda database due to missing event code and exceeded characters.Initial mdr was submitted as joint report for manufacturer and initial importer.The initial mdr of this incident was submitted to the fda within the original reporting deadline.This submission represents a reload of data to ensure correct upload to the fda database.

Event Description

The new laryngeal mask was inserted into a patient, there was no hole in the tubing for the oxygen and sevoflurane to enter.

• Brand Name: AURA 40 REUSABLE
• Type of Device: LARYNGEAL MASK
• Manufacturer (Section D): BESMED HEALTH BUSINESS CORPORATION; no. 5, lane 116; wu-kong 2nd r; new taipei city, special municip 24888 ; TW 24888
• Manufacturer (Section G): BESMED HEALTH BUSINESS CORPORATION; no. 5, lane 116; wu-kong 2nd r; new taipei city, special municip 24888 ; TW 24888
• Manufacturer Contact: sanjay parikh ; no. 5, lane 116; wu-kong 2nd r; new taipei city, special municip 24888 ; TW 24888
• MDR Report Key: 12142055
• MDR Text Key: 263123150
• Report Number: 3003256355-2018-00001
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/10/2018

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 Catalogue Number: 340400000
• Device Lot Number: 703F154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention