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

Model Number 37207

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 12/08/2020

Event Type  malfunction  

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.Resmed reference #: (b)(4).

Event Description

It was allegedly reported to resmed that an airsense 10 autoset caught fire.The device was not in patient use when the reported event occurred.

Event Description

It was allegedly reported to resmed that an airsense 10 autoset caught fire.The device was not in patient use when the reported event occurred.

Manufacturer Narrative

The airsense 10 autoset device was returned to resmed for an investigation.Visual inspection revealed evidence of water damage to the dc connector, filter cover burnt and melted, evidence of burnt and heat damage to pneumatic block motor.The investigation determined that there is no evidence that the source of ignition came from the device itself.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference #: (b)(4).

• 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: 11096395
• MDR Text Key: 225270158
• Report Number: 3004604967-2020-01284
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K140124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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
• 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: 12/10/2020
• Distributor Facility Aware Date: 03/15/2021
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1