AIRFIT F20 MED SYS - EU1 63406

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-02-05 for AIRFIT F20 MED SYS - EU1 63406 manufactured by Resmed Ltd.

Event Text Entries

[177931628] No further information is available. The airfit f20 user guide provides the following warning and contraindications: magnets are used in the lower headgear straps and the frame of the mask. Ensure the headgear and frame is kept at least 2" (50 mm) airway from any active medical implant (e. G. , pacemaker or defibrillator) to avoid possible effects from localized magnetic fields. The magnetic field strength is less than 400 mt. Contraindications: use of masks with magnetic components is contraindicated in patients with the following pre-existing conditions: metallic hemostatic clip implanted in your head to repair an aneurysm metallic splinters in one or both eyes following a penetrating eye injury. Under normal use scenarios (the mask is on the face), the risks posed by the mask causing interference to active cardiac implants are temporary, infrequent and have a very low chance of causing significant harm. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[177931629] It was reported to resmed that a magazine article stated that during use of an airfit f20 mask, a patient felt progressively weak. It was reported the patient's implanted defibrillator had automatically reprogrammed and had impaired function allegedly due to the magnetic fasteners of the mask. It was reported the patient was hospitalized as a result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004604967-2020-00218
MDR Report Key9673966
Report SourceFOREIGN
Date Received2020-02-05
Date of Report2020-02-05
Date Facility Aware2020-01-07
Date Mfgr Received2020-01-07
Date Added to Maude2020-02-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS. MICHELLE HUGHES
Manufacturer Street1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA
Manufacturer CitySYDNEY, NSW 2153
Manufacturer CountryAU
Manufacturer Postal2153
Manufacturer G1RESMED LTD
Manufacturer Street1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA
Manufacturer CitySYDNEY, NSW 2153
Manufacturer CountryAU
Manufacturer Postal Code2153
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAIRFIT F20 MED SYS - EU1
Product CodeBZD
Date Received2020-02-05
Model Number63406
Catalog Number63406
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerRESMED LTD
Manufacturer Address1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA SYDNEY, NSW 2153 AU 2153


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-05

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