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

Model Number 63001

Device Problem Obstruction of Flow (2423)

Patient Problem Dyspnea (1816)

Event Date 11/18/2020

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.(b)(4).

Event Description

It was reported to resmed that a patient using an airtouch f20 full face mask could not breathe against the mask due to the mask valve remaining shut.It was reported the patient had the same mask for two years.There was no serious injury reported as a result of this incident.

• Brand Name: AIRTOUCH F20 MED - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11023800
• MDR Text Key: 222312361
• Report Number: 3004604967-2020-01195
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K153563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 63001
• Device Catalogue Number: 63001
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/18/2020
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1