MAUDE Adverse Event Report: RESMED LTD AIRCURVE 10 VAUTO 3G CO

Model Number	37406
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.The aircurve 10 vauto user guide states the following indications for use: ¿the aircurve 10 vauto device is indicated for the treatment of obstructive sleep apnea (osa) in patients weighing more than (b)(6).It is intended for home and hospital use.¿ it delivers continuous positive airway pressure to a spontaneously breathing patient.It is not intended to be used as a life support ventilator.Resmed reference #: (b)(4).
Event or Problem Description
It was reported to resmed that an aircurve 10 device suddenly stopped working while in use on a patient under general anesthesia during surgery.It was reported the device was not able to power back on, the surgery was stopped and the patient was administered oxygen.There was no serious injury reported as a result of this incident.

• Brand Name: AIRCURVE 10 VAUTO 3G CO
• 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: 13501153
• Report Number: 3004604967-2022-00091
• Device Sequence Number: 17365001
• Product Code: BZD
• UDI-Device Identifier: 00619498374069
• UDI-Public: (01)00619498374069(10)1335448
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 37406
• Device Catalogue Number: 37406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/12/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/09/2022
• Date Device Manufactured: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Unknown