MAUDE Adverse Event Report: RESMED PTY LTD AIRFIT F30I SYS - M/STD - AMER; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	63332
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Codes	Fall (1848); Memory Loss/Impairment (1958); Dizziness (2194); Loss of consciousness (2418); Irritability (2421); Confusion/ Disorientation (2553); Psychosis (4593)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to resmed so that an engineering investigation can be performed.Therefore, resmed is unable to confirm the alleged malfunction at this time.Airfit f30i user guide includes the following contraindication: "masks with magnetic components are contraindicated for use by patients where they, or anyone in close physical contact while using the mask, have active medical implants that interact with magnets (i.E., pacemakers, implantable cardioverter defibrillators (icd), neurostimulators, cerebrospinal fluid (csf) shunts, insulin/infusion pumps)." airfit f30i user guide includes the following warning: - ¿keep the mask magnets at a safe distance of at least 6 inches (150 mm) away from implants or medical devices that may be adversely affected by magnetic interference.This warning applies to you or anyone in close physical contact with your mask.The magnets are in the frame and lower headgear clips, with a magnetic field strength of up to 400mt.When worn, they connect to secure the mask but may inadvertently detach while asleep.Implants/medical devices, including those listed within contraindications, may be adversely affected if they change function under external magnetic fields or contain ferromagnetic materials that attract/repel to magnetic fields (some metallic implants, e.G., contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, and bone substitute devices).Consult your physician and manufacturer of your implant / other medical device for information on the potential adverse effects of magnetic fields.¿ resmed reference #: pr 3189600; fda voluntary medwatch report: mw5159515.
Event or Problem Description
It was reported to resmed that the magnets of an airfit f30i mask allegedly caused the settings of a patient's adjustable magnetic ventriculoperitoneal shunt to shift resulting in too much flow of cerebrospinal fluid.Patient required transport to the hospital.Patient has switched to a non-magnetic mask.Patient did not have symptoms prior to use of the mask.

• Brand Name: AIRFIT F30I SYS - M/STD - AMER
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 20645928
• Report Number: 3004604967-2024-00367
• Device Sequence Number: 15311424
• Product Code: BZD
• UDI-Device Identifier: 00619498633326
• UDI-Public: 619498633326
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 63332
• Device Catalogue Number: 63332
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/15/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White