MAUDE Adverse Event Report: RESMED LTD AIRSENSE 10 AUTOSET USA TRI

Model Number 37208

Device Problem Fire (1245)

Patient Problem Insufficient Information (4580)

Event Date 09/25/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to resmed for an evaluation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an airsense 10 device was involved in a house fire.The device was not in patient use when the reported event occurred.

Event Description

It was reported to resmed that an airsense 10 device was involved in a house fire.The device was not in patient use when the reported event occurred.

Manufacturer Narrative

The astral device was not returned to resmed.An investigation was performed on all available information.Based on the available information, there is no conclusive evidence at this time to indicate whether the airsense 10 device or usb hub caused the fire.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

• Brand Name: AIRSENSE 10 AUTOSET USA TRI
• 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: 12862879
• MDR Text Key: 282336064
• Report Number: 3004604967-2021-01179
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498372089
• UDI-Public: (01)00619498372089(10)1277665
• 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
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 37208
• Device Catalogue Number: 37208
• Device Lot Number: 1277665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/18/2022
• Date Manufacturer Received: 03/18/2022
• Date Device Manufactured: 12/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female