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

Model Number 37203

Device Problem Increase in Pressure (1491)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2021

Event Type  malfunction  

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 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
• MDR Text Key: 279794933
• Report Number: 3007573469-2021-01086
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498372119
• UDI-Public: (01)00619498372119(10)1203211
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 37203
• Device Catalogue Number: 37203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2021
• Distributor Facility Aware Date: 09/21/2021
• Device Age: 58 MO
• Date Report to Manufacturer: 10/19/2021
• Date Manufacturer Received: 09/21/2021
• Date Device Manufactured: 10/31/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR