MAUDE Adverse Event Report: RESMED LTD AIRFIT F20 LGE SYS - ANZ

Model Number 63432

Device Problem Electromagnetic Interference (1194)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested the device to be returned so that an 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 by a physician that an airfit f20 mask caused magnetic interference to a patient's brain after brain surgery.It was reported that the mask was removed from the patient and replaced with a different mask.There was no patient harm or serious injury reported as a result of this event.

• Brand Name: AIRFIT F20 LGE SYS - ANZ
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: ariana beck ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 7701134
• MDR Text Key: 114676867
• Report Number: 3004604967-2018-01042
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K153563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2018

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: Health Professional
• Device Model Number: 63432
• Device Catalogue Number: 63432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/18/2018
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1