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

Model Number	37210
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received by resmed and an evaluation was performed.The reported failure could not be reproduced during evaluation and the device operated per specifications.The device was serviced, cleaned, calibrated and tested before it was returned to the customer.The airsense 10 device has hardware and software mitigations in place which cease heating to the tubing when breaths are not detected (i.E.When mask is off) and when the temperature of the air and/or tubing rises above 41 degrees.Resmed includes the following statement in the airsense 10 user guide ¿ ¿blocking the air tubing and/or air inlet of the device while in operation could lead to overheating of the device.¿ resmed reference #: (b)(4).
Event or Problem Description
It was reported to resmed that climateline air tubing used with an airsense 10 device allegedly burned the patient's arms.It was reported that the patient was asleep in her bed, awoke and noticed burns to her right and left arm near the elbows.It was reported the patient visited urgent care and was advised to apply over the counter ointment to the skin.The patient reportedly visited a physician assistant and was advised the entire healing process may take a few months, hyperpigmentation may take several months to years to resolve and may not resolve completely.The patient is currently recovering and has bandages on her arms.

• Brand Name: AIRSENSE 10 AUTOSET FH USA TRI
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12243504
• Report Number: 3004604967-2021-00825
• Device Sequence Number: 19611190
• Product Code: BZD
• UDI-Device Identifier: 00619498372102
• UDI-Public: (01)00619498372102(10)1519420
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K140124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 37210
• Device Catalogue Number: 37210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Distributor Facility Aware Date: 06/29/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR