Telford, PA, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Draeger, Inc., a subsidiary of Draegerwerk AG & Co. KGaA, is alerting users to updated instructions for use (IFU) for the NovaStar TS Full Face Mask, which is used for non-invasive ventilation therapy.
The NovaStar TS mask contains magnets in the swivel frame/tube set and headgear clips. If the magnets in the NovaStar TS mask are positioned near medical devices (implanted as well as not implanted) or metallic implants/objects, the magnetic field might impact the implants or devices and cause serious injury.
Draeger is updating the NovaStar TS mask IFU to include a contraindication for patients, and other persons in close vicinity to patients using the masks, who have metallic implanted devices or metallic objects in their bodies.
The NovaStar TS masks in the below table were imported by Draeger, Inc. from Draegerwerk AG & Co. KGaA and distributed in the U.S. between January 1, 2017, and December 31, 2022. A total of 909 masks were distributed. All lot numbers are affected.
| Product Name | Material Number | UDI Number |
| NovaStar TS with Anti-Asphyxia Valve, Reusable Size S | MP01576 | 04048675041146 |
| NovaStar TS with Anti-Asphyxia Valve, Reusable Size M | MP01577 | 04048675041153 |
| NovaStar TS with Anti-Asphyxia Valve, Reusable Size L | MP01578 | 04048675041160 |
| NovaStar TS with Standard Elbow, Reusable Size S | MP01579 | 04048675040552 |
| NovaStar TS with Standard Elbow, Reusable Size M | MP01580 | 04048675040569 |
| NovaStar TS with Standard Elbow, Reusable Size L | MP01581 | 04048675040538 |
Patients should stop using the NovaStar TS mask if the implant/medical device is contraindicated against the mask magnets. Patients should consult their physician immediately to determine if another mask can be used for their therapy. In the interim, switch to a non-magnetic mask, if available, for continued therapy. Patients should properly dispose of the mask that has magnets after an alternative is obtained. These masks may continue to be used according to these updated instructions if patients or people in close proximity to them do not have implanted metallic medical devices or metallic implants in their body.
This is a voluntary notification to users of the NovaStar TS masks to inform them of the updated instructions. All users should read and follow Draeger’s voluntarily updated warning and added contraindication described below.
Contraindication: Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to:
- Pacemakers
- Implantable cardioverter defibrillators (ICD)
- Neurostimulators
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso or higher (e.g., neck and head)
- Cerebral spinal fluid (CSF) shunts (e.g., ventriculoperitoneal (VP) shunt)
- Aneurysm clips
- Embolic coils
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates, screws, burr hole covers, and bone substitute devices
- Metallic splinters in the eye
- Ocular implants (e.g., glaucoma implants, retinal implants)
- Certain contact lenses with metal
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
- Magnetic denture attachments
- Metallic gastrointestinal clips
- Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
- Implantable ports and pumps (e.g., insulin pumps)
- Hypoglossal nerve stimulators
- Devices labeled as MR (Magnetic Resonance) unsafe
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
Warning: The magnetic field strength of the NovaStar TS magnets is 380mT. With the exception of the devices identified in the contraindication, ensure the mask is kept at least 6 inches (approx. 15 cm) away from any medical implants or medical devices that can be impacted by the magnetic fields to avoid possible effects from localized magnetic fields. This includes household members, caregivers and bed partners that may be in close proximity to patients that use the masks.
Draeger is not aware of any reports suggesting that a NovaStar TS mask impacted medical devices (implanted as well as not implanted) or metallic implants, to date.
If you have any questions, you may contact Michael Kelhart between the hours of 8:00 AM – 4:30 PM EST at 267-664-1131 or via email at mike.kelhart@draeger.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program whether online, by regular mail or by fax.
- Complete and submit the report online
- Regular mail or fax: Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Affected customers have been notified. This voluntary medical device correction has been reported to the FDA.
Draeger. Technology for Life®
Draeger is an international leader in the fields of medical and safety technology. Our products protect, support, and save lives. Founded in 1889, Draeger generated revenues of around EUR 3.3 billion in 2021. The Draeger Group is currently present in over 190 countries and has more than 15,000 employees worldwide. Please visit www.draeger.com for more information.
Attachments
