MAUDE Adverse Event Report: RESMED LTD AIRSENSE 10 CPAP USA CO

Model Number 37203

Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017)

Patient Problem Aspiration/Inhalation (1725)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.The airsense 10 clinical guide provides the following instructions: - ¿if rainout does occur, first try increasing the tube temperature.If the air temperature becomes too warm and rainout continues, try decreasing the humidity." resmed reference #: (b)(4).

Event Description

It was reported to resmed that a patient mistakenly turned the humidity of his airsense 10 device up to 8 which caused excess water moisture within the patient¿s nasal mask that the patient aspirated.It was reported the patient visited an emergency department 2 days later due to this incident and is currently recovering.

• Brand Name: AIRSENSE 10 CPAP USA CO
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12278404
• MDR Text Key: 265125609
• Report Number: 3004604967-2021-00838
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498372034
• UDI-Public: (01)00619498372034(10)1516501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37203
• Device Catalogue Number: 37203
• Device Lot Number: 1516501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/06/2021
• Date Manufacturer Received: 07/06/2021
• Date Device Manufactured: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 88