MAUDE Adverse Event Report: RESMED LTD AIRFIT F30I SYS - M/STD - EU

Model Number 63312

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886)

Patient Problem Anaphylactic Shock (1703)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned to resmed for an engineering investigation.The investigation methods, results and conclusion are not finalized at this stage.When more information is available, a supplemental report will be submitted.(b)(4).Pending evaluation.

Event Description

It was reported to resmed that a patient experienced dyspnea, painful breathing and urticaria within 30 minutes of using a new airfit f30i mask.The patient was transported to the emergency department and diagnosed with an anaphylactic reaction most likely due to the mask.The patient has recovered from the incident.

Event Description

It was reported to resmed that a patient experienced dyspnea, painful breathing and urticaria within 30 minutes of using a new airfit f30i mask.The patient was transported to the emergency department and diagnosed with an anaphylactic reaction most likely due to the mask.The patient has recovered from the incident.

Manufacturer Narrative

The mask was returned to resmed for an investigation.Visual inspection of the mask did not reveal any visible anomalies.The user guide for airfit f30i provides the following warning ¿ ¿discontinue using this mask if you have any adverse reaction to the use of the mask, and consult your physician or sleep therapist¿.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

• Brand Name: AIRFIT F30I SYS - M/STD - EU
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11078809
• MDR Text Key: 223823970
• Report Number: 3007573469-2020-01264
• 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,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 63312
• Device Catalogue Number: 63312
• Device Lot Number: 1444732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2021
• Distributor Facility Aware Date: 03/05/2021
• Event Location: Home
• Date Report to Manufacturer: 03/24/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1