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

Model Number 37205

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2020

Event Type  malfunction  

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, therefore, resmed is unable to confirm the alleged malfunction at this time.(b)(4).

Event Description

It was allegedly reported to resmed that an airsense 10 elite device caught fire.There was no patient harm or a serious injury reported as a result of this incident.

Event Description

It was allegedly reported to resmed that an airsense 10 elite device caught fire.There was no patient harm or a serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Visual inspection revealed exterior fire damage to the device with no internal fire damage.The device was functional.The investigation determined the root cause is not related to device.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

• Brand Name: AIRSENSE 10 ELITE USA CO
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11078008
• MDR Text Key: 224597831
• Report Number: 3004604967-2020-01261
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498372058
• UDI-Public: (01)00619498372058(10)1335782
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 37205
• Device Catalogue Number: 37205
• Device Lot Number: 1335782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Distributor Facility Aware Date: 03/03/2021
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 106