MAUDE Adverse Event Report: RESMED LTD AIRSENSE 11 AUTOSET USA TRI

Model Number 39001

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  malfunction  

Event Description

It was reported to resmed that an airsense 11 power cord caught fire.There was no patient harm or a serious injury reported as a result of this incident.

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).Pending evaluation.

Manufacturer Narrative

The airsense 11 device and power cord were returned to resmed for an investigation.Visual inspection revealed pinch points on the ac power cord, rough patches on the jacket of the ac power cord and no burn marks on the device or power supply unit.The device and power supply unit were performing to specifications with a known good ac power cord.Based on all available evidence, the investigation determined that the reported complaint was due to physical abuse.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.(b)(4).

Event Description

It was reported to resmed that an airsense 11 power cord caught fire.There was no patient harm or a serious injury reported as a result of this incident.

• Brand Name: AIRSENSE 11 AUTOSET USA TRI
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12912717
• MDR Text Key: 282960340
• Report Number: 3004604967-2021-01192
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498390014
• UDI-Public: (01)00619498390014(10)1563611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 39001
• Device Catalogue Number: 39001
• Device Lot Number: 1563611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/27/2022
• Date Manufacturer Received: 02/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 130 KG