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

Model Number 37207

Device Problem Pressure Problem (3012)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to resmed that an airsense 10 autoset had a pressure issue and the patient experienced a lack of air, developed heart attack-like symptoms and was taken to the hospital.It was reported the patient recovered.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an airsense 10 autoset had a pressure issue and the patient experienced a lack of air, developed heart attack-like symptoms and was taken to the hospital.It was reported the patient recovered.

• Brand Name: AIRSENSE 10 AUTOSET USA CO
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9522335
• MDR Text Key: 172809381
• Report Number: 3004604967-2019-00486
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498372072
• UDI-Public: (01)00619498372072(10)1399441
• Combination Product (y/n): N
• PMA/PMN Number: K140124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37207
• Device Catalogue Number: 37207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Distributor Facility Aware Date: 05/13/2020
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1