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.
[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
| Report Number | 3004604967-2020-00218 |
| MDR Report Key | 9673966 |
| Report Source | FOREIGN |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date Facility Aware | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-02-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MICHELLE HUGHES |
| Manufacturer Street | 1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA |
| Manufacturer City | SYDNEY, NSW 2153 |
| Manufacturer Country | AU |
| Manufacturer Postal | 2153 |
| Manufacturer G1 | RESMED LTD |
| Manufacturer Street | 1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA |
| Manufacturer City | SYDNEY, NSW 2153 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 2153 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRFIT F20 MED SYS - EU1 |
| Product Code | BZD |
| Date Received | 2020-02-05 |
| Model Number | 63406 |
| Catalog Number | 63406 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED LTD |
| Manufacturer Address | 1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA SYDNEY, NSW 2153 AU 2153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |