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 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received by resmed without the power cord.An evaluation was performed, however, since incomplete device was returned, resmed is unable to confirm the alleged malfunction at this time.The customer was provided a replacement device.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that the power cord of an airsense 10 device caught fire.The device was not in patient use when the reported event occurred.There was no patient harm or a serious injury reported as a result of this incident.

Manufacturer Narrative

The device was received by resmed and an evaluation was performed.The reported complaint could not be confirmed during evaluation.An investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that the power cord of an airsense 10 device caught fire.The device was not in patient use when the reported event occurred.There was no patient harm or a serious injury reported as a result of this incident.

• 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: 10588193
• MDR Text Key: 208599259
• Report Number: 3007573469-2020-00929
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498372072
• UDI-Public: (01)00619498372072(10)1343307
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• 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
• Device Lot Number: 1343307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/24/2020
• Distributor Facility Aware Date: 11/02/2020
• Device Age: 21 MO
• Event Location: Home
• Date Report to Manufacturer: 11/24/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 123