MAUDE Adverse Event Report: RESMED LTD AIRFIT F20 MED - AMER

Model Number 63401

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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's risk analysis for this failure mode concludes that the risk is acceptable.The initial medwatch report was submitted in error under a previous single mdr exemption approval, this resubmission is done to correct the error.Previously submitted medwatch report number 3004604967-2019-00210 / 3007573469-2019-00210.Resmed reference #: (b)(4).

Event Description

It was reported to resmed the backflow device flaps of the ffm airfit f20 do not close when the mask is under pressure potentially leading to oxygen starvation and death.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: AIRFIT F20 MED - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11047546
• MDR Text Key: 241254706
• Report Number: 3007573469-2020-01211
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 63401
• Device Catalogue Number: 63401
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2020
• Distributor Facility Aware Date: 06/19/2019
• Date Report to Manufacturer: 12/21/2020
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1