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

Model Number	37203
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.Resmed reference # (b)(4).Medwatch report# 5103682.
Event or Problem Description
It was reported to resmed that the pressure delivered from an airsense 10 cpap was greater than 30 psi.Serious injury with required intervention was reported.No further information was provided.

• Brand Name: AIRSENSE 10 CPAP USA CO
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12662680
• Report Number: 3007573469-2021-01086
• Device Sequence Number: 11389698
• Product Code: BZD
• UDI-Device Identifier: 00619498372119
• UDI-Public: (01)00619498372119(10)1203211
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2021
• Report Date (Section F): 10/19/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 37203
• Device Catalogue Number: 37203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/21/2021
• Device Age: 58 MO
• Date Report to Manufacturer: 10/19/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Date Report Sent to FDA: 10/19/2021