MAUDE Adverse Event Report: RESMED LTD AIRFIT F30 SML SYS - AMER

Model Number 64100

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested for the products to be returned so that an engineering investigation could be performed.The products have not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.The reportable event occurred outside the us.During a routine check of complaints records it was detected that the event is reportable in the us.This report is being submitted to correct the error.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that during use of airfit f30 full face masks, 'non-vented mask' alarms are occurring.It was reported visual inspection of the quiet air vent of the masks revealed blockage (hair, build-up, etc.).There was no reported patient harm or an injury as a result of this incident.

• Brand Name: AIRFIT F30 SML SYS - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9560790
• MDR Text Key: 188554570
• Report Number: 3007573469-2020-00025
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 64100
• Device Catalogue Number: 64100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2020
• Distributor Facility Aware Date: 11/15/2019
• Date Report to Manufacturer: 01/07/2020
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1