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

Model Number	37208
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional 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 or any evidence of the malfunction provided, therefore, resmed is unable to confirm the alleged malfunction at this time.In addition, the alleged injury has not been confirmed, or any medical statements provided from the patient or medical professional.(b)(4).
Event or Problem Description
It was reported to resmed that a piece of an airsense 10 and mask was allegedly dislodged, and went up the patient's nose by the pressure of the device causing facial pain, leaving a red mark on side of face, and bleeding from the nose & mouth.The patient has alleged to have sought medical attention at an urgent care clinic and was referred to an ear nose & throat specialist.Resmed has not been provided any medical statements from the patient or a medical professional.

• Brand Name: AIRSENSE 10 AUTOSET USA TRI
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 10141475
• Report Number: 3007573469-2020-00651
• Device Sequence Number: 2850280
• Product Code: BZD
• UDI-Device Identifier: 00619498372089
• UDI-Public: (01)00619498372089(10)1435196
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2020
• Report Date (Section F): 06/05/2020

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: 37208
• Device Catalogue Number: 37208
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/12/2020
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 06/05/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59
• Patient Weight: 75
• Date Report Sent to FDA: 06/05/2020