MAUDE Adverse Event Report: RESMED LTD AIRSENSE 10 AUTOSET FR

Model Number 37236

Device Problem Fire (1245)

Patient Problem Injury (2348)

Event Date 08/26/2020

Event Type  Injury  

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

Event Description

It was reported to resmed that an airsense 10 device caught fire while connected to main power source.The device was not in use on a patient at the time of the incident.The patient was hospitalized for an undisclosed reason following the incident.The patient has recovered and is continuing therapy with a new device.

Manufacturer Narrative

The investigation determined that there was no fault found with the device.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an airsense 10 device caught fire while connected to main power source.The device was not in use on a patient at the time of the incident.The patient was hospitalized for an undisclosed reason following the incident.The patient has recovered and is continuing therapy with a new device.

• Brand Name: AIRSENSE 10 AUTOSET FR
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 10840848
• MDR Text Key: 216306962
• Report Number: 3004604967-2020-01086
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37236
• Device Catalogue Number: 37236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Distributor Facility Aware Date: 02/23/2021
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1