MAUDE Adverse Event Report: RESMED LTD AIRSENSE 10 CPAP - 4G; Ventilator, non-continuous (respirator)

Model Number 37088

Device Problems Use of Device Problem (1670); Pressure Problem (3012)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

Resmed has requested for the device and mask to be returned so that an engineering investigation can be performed.The products have not been returned, therefore, resmed is unable to evaluate the performance and integrity of the products.The airsense 10 user guide provides the following warning about possible adverse effects: ¿the following side effects may arise during the course of therapy with the machine: drying of the nose, mouth, or throat, nosebleed, bloating, ear or sinus discomfort, eye irritation, skin rashes.¿ resmed mask user guide provides 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

It was reported to resmed that a patient experienced gum deformation and teeth loss allegedly due to use of resmed devices and the pressure of the mask over the patient's mouth.The patient consulted with their pulmonologist and has since changed from an airfit f20 mask to an airfit n30i mask and a bipap device from a cpap device.Further information regarding the patient¿s medical history and existing dental conditions has not been made available to resmed.

Manufacturer Narrative

Resmed has requested for the device and mask to be returned so that an engineering investigation can be performed.The products have not been returned, therefore, resmed is unable to evaluate the performance and integrity of the products.The airsense 10 user guide provides the following warning about possible adverse effects: - ¿the following side effects may arise during the course of therapy with the machine: drying of the nose, mouth, or throat , nosebleed, bloating, ear or sinus discomfort, eye irritation, skin rashes.¿ resmed mask user guide provides 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

It was reported to resmed that a patient experienced gum deformation and teeth loss allegedly due to use of resmed devices and the pressure of the mask over the patient's mouth.The patient consulted with their pulmonologist and has since changed from a cpap device to bipap device.The patient has used an airfit f20, airfit f10, ultra mirage, quatro full face mask and is currently using an airfit n30i mask.Further information regarding the patient¿s medical history and existing dental conditions has not been made available to resmed.

• Brand Name: AIRSENSE 10 CPAP - 4G
• Type of Device: Ventilator, non-continuous (respirator)
• 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: 16428616
• MDR Text Key: 310102073
• Report Number: 3004604967-2023-00123
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37088
• Device Catalogue Number: 37088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/22/2023
• Date Manufacturer Received: 02/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 127 KG