MAUDE Adverse Event Report: RESMED LTD AIRFIT N20 MED SYS - EU1; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 63511

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

The mask has not been returned to resmed therefore, resmed is unable to evaluate the performance and integrity of the mask.If further information becomes available, a supplementary report will be submitted.The airfit n20 user guide includes the following warnings: "discontinue using this mask if you have any adverse reaction to the use of the mask, and consult your physician or sleep therapist.Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition.If symptoms occur, consult your physician or dentist.Magnets are used in the lower headgear straps and the frame of the airfit n20.Ensure the headgear and frame is kept at least 2"" (50 mm) away from any active medical implant (eg, pacemaker or defibrillator) to avoid possible effects from localized magnetic fields.The magnetic field strength is less than 400 mt." resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient's dental metalwork (screw, metal dental frame, metal caps) performed on the maxillary and mandibular teeth failed and disappeared resulting in the destruction of the surrounding teeth allegedly due to an airfit n20 nasal mask.It was reported that the patient used a competitor cpap device with their mask and had no problems with their teeth prior to using the device and the mask.The patient alleged that they were never warned that this could be a problem and stated that per their dentist and oral surgeon, the only long term solution is to have a full mouth extraction and full arch dental implants.

• Brand Name: AIRFIT N20 MED SYS - EU1
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 17301679
• MDR Text Key: 318925870
• Report Number: 3007573469-2023-00428
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 00619498635115
• UDI-Public: (01)00619498635115(10)1460553
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 63511
• Device Catalogue Number: 63511
• Device Lot Number: 1460553
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2023
• Distributor Facility Aware Date: 06/12/2023
• Device Age: 35 MO
• Date Report to Manufacturer: 07/11/2023
• Date Manufacturer Received: 06/12/2023
• Date Device Manufactured: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female