MAUDE Adverse Event Report: RESMED LTD AIRFIT F20 FRAME SYS MED

Model Number 63461

Device Problem Compatibility Problem (2960)

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

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.(b)(4).

Event Description

It was reported to resmed that the magnets of an airfit f20 headgear affected the patient¿s programmable vp shunt and changed his inner cranial pressure.It was reported the patient went to the emergency department to reduce the pressure and restore the ability to function.

• Brand Name: AIRFIT F20 FRAME SYS MED
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9454603
• MDR Text Key: 170428433
• Report Number: 3004604967-2019-00443
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• PMA/PMN Number: K170924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 63461
• Device Catalogue Number: 63461
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/14/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1