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

Model Number 37208

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/13/2020

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 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 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
• MDR Text Key: 194758448
• Report Number: 3007573469-2020-00651
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498372089
• UDI-Public: (01)00619498372089(10)1435196
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37208
• Device Catalogue Number: 37208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2020
• Distributor Facility Aware Date: 05/12/2020
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 06/05/2020
• Date Manufacturer Received: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59
• Patient Weight: 75