MAUDE Adverse Event Report: RESMED LTD SWIFT FX NASAL PILLOWS SYSTEM

Model Number 61504

Device Problem Human-Device Interface Problem (2949)

Patient Problems Hearing Loss (1882); Blurred Vision (2137); Dizziness (2194)

Event Type  Injury  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned; therefore, resmed is unable to confirm the alleged malfunction at this time.The user guide for the "siwft" fx 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 reference #: (b)(4).

Event Description

The tga reported to resmed that a patient alleged the use of a swift fx mask was crushing into the patient's skull, which caused constant vertigo, loss of high-tone hearing in one ear, potential brain damage and blurry vision.The patient alleged that they can neither read, drive nor walk properly and are on medication.

• Brand Name: SWIFT FX NASAL PILLOWS SYSTEM
• 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: 8232207
• MDR Text Key: 132567118
• Report Number: 3004604967-2019-00030
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K123789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 61504
• Device Catalogue Number: 61504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/10/2018
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1