MAUDE Adverse Event Report: RESMED LTD N20 HEADGEAR - STD RP

Model Number 63547

Device Problem Pressure Problem (3012)

Patient Problem Tooth Fracture (2428)

Event Date 12/16/2022

Event Type  Injury  

Event Description

It was reported to resmed that a patient's back lower left tooth cracked allegedly due to the pressure applied by the headgear clip of an airfit n20 mask.

Manufacturer Narrative

A crown was placed on the patient's broken tooth to address the issue.Patient switched to using an older style resmed mask.Resmed has requested for the device to be returned so that an investigation can be performed.The device has not been returned to resmed.The airfit n20 user guide provides warning on this potential effect: ¿using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition.If symptoms occur, consult your physician or dentist." resmed reference #: (b)(4).

• Brand Name: N20 HEADGEAR - STD RP
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 16153516
• MDR Text Key: 307261851
• Report Number: 3004604967-2023-00034
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 63547
• Device Catalogue Number: 63547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/16/2022
• Date Manufacturer Received: 12/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female