MAUDE Adverse Event Report: RESMED LTD AIRFIT P10 MASK SYSTEM - AMER

Model Number 62900

Device Problem Pressure Problem (3012)

Patient Problem Tooth Fracture (2428)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to resmed for evaluation.The information provided by the patient indicates they had a prexisting dental condition.This condition may have been exacerbated by the use of the mask and led to the patient's tooth removal.Resmed requested the mask be returned for an engineering investigation.The mask was not returned therefore, no device investigation was performed.The airfit p10 user guide contains the following warning: ¿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).

Event Description

A patient reported that they experienced tooth loss after using a airfit p10 mask.

• Brand Name: AIRFIT P10 MASK SYSTEM - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney 2153 ; AU 2153
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 6012888
• MDR Text Key: 56928933
• Report Number: 3004604967-2016-01094
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 62900
• Device Catalogue Number: 62900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/09/2016
• Date Manufacturer Received: 09/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1