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

Model Number 63401

Device Problem Obstruction of Flow (2423)

Patient Problem Hypoxia (1918)

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 reference #: (b)(4).

Event Description

It was reported to resmed that the valves of the ffm airfit f20 are defective which resulted in the patient reporting symptoms suggestive of hypoxia and hypercarbia.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 CORP; 9001 spectrum center blvd; san diego CA 92123
• MDR Report Key: 8787679
• MDR Text Key: 150957059
• Report Number: 3007573469-2019-00215
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2019
• Distributor Facility Aware Date: 06/14/2019
• Date Report to Manufacturer: 07/12/2019
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1