AIRFIT F20 MASK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-05 for AIRFIT F20 MASK manufactured by Resmed Ltd..

MAUDE Entry Details

• Report Number: MW5087164
• MDR Report Key: 8674931
• Date Received: 2019-06-05
• Date of Report: 2019-05-28
• Date of Event: 2019-05-27
• Date Added to Maude: 2019-06-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: AIRFIT F20 MASK
• Generic Name: MASK, OXYGEN
• Product Code: BYG
• Date Received: 2019-06-05
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RESMED LTD.

Device Sequence Number: 2

• Brand Name: AIRFIT F20 MASK
• Generic Name: MASK, OXYGEN
• Product Code: BYG
• Date Received: 2019-06-05
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: RESMED LTD.

Device Sequence Number: 3

• Brand Name: AIRFIT F20 MASK
• Generic Name: MASK, OXYGEN
• Product Code: BYG
• Date Received: 2019-06-05
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: RESMED LTD.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2019-06-05