MAUDE Adverse Event Report: RESMED LTD AIRSENSE 10 CPAP USA CO

Model Number	37203
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.The airsense 10 clinical guide provides the following instructions: - ¿if rainout does occur, first try increasing the tube temperature.If the air temperature becomes too warm and rainout continues, try decreasing the humidity." resmed reference #: (b)(4).
Event or Problem Description
It was reported to resmed that a patient mistakenly turned the humidity of his airsense 10 device up to 8 which caused excess water moisture within the patient¿s nasal mask that the patient aspirated.It was reported the patient visited an emergency department 2 days later due to this incident and is currently recovering.

• Brand Name: AIRSENSE 10 CPAP USA CO
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12278404
• Report Number: 3004604967-2021-00838
• Device Sequence Number: 4507354
• Product Code: BZD
• UDI-Device Identifier: 00619498372034
• UDI-Public: (01)00619498372034(10)1516501
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K140124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 37203
• Device Catalogue Number: 37203
• Device Lot Number: 1516501
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 88