MAUDE Adverse Event Report: RESMED PTY LTD AIR 10 PSU 90W EUR II; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 37476

Device Problems Fire (1245); Melted (1385)

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

Event Date 09/30/2023

Event Type  malfunction  

Manufacturer Narrative

The air 10 psu has been returned to resmed for an engineering investigation.Visual inspection revealed thermal damage of the psu where the power cord connects from the airsense 10 device to the psu.The investigation methods, results and conclusion are not finalized at this stage.A supplemental report will be submitted when further information becomes available.The airsense 10 device user guide states: "make sure the power cord and plug are in good condition and the equipment is not damaged.If you notice any unexplained changes in the performance of the device, if it is making unusual sounds, if the device or the power supply are dropped or mishandled, or if the enclosure is broken, discontinue use and contact your care provider or your resmed service center.Keep the area around the device dry, clean and clear of anything (eg, clothes or bedding) that could block the air inlet or cover the power supply unit." resmed reference#: (b)(4).

Event Description

It was reported to resmed that an air10 power supply unit (psu) caught fire, began to melt and self-extinguished after the airsense 10 device was powered on and while plugged into a power strip.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: AIR 10 PSU 90W EUR II
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 18243704
• MDR Text Key: 329427602
• Report Number: 3004604967-2023-00660
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 37476
• Device Catalogue Number: 37476
• Device Lot Number: DL86716N11006385800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/31/2023
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1