MAUDE Adverse Event Report: RESMED PTY LTD AIRCURVE 10 ST USA TRI; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	37307
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
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.If further information becomes available, a supplemental report will be submitted.Resmed reference#: (b)(4).Voluntary medwatch reference: mw5183555.
Event or Problem Description
It was reported to resmed that an aircurve 10 st device unexpectedly shut down during use on a hospitalized hospice patient.It was reported that the interruption in therapy resulted in significant oxygen desaturations.It was reported that the patient¿s discharge from the hospital was delayed.Therapy was continued using a replacement device.

• Brand Name: AIRCURVE 10 ST USA TRI
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153 ; 426226675
• MDR Report Key: 24747533
• Report Number: 3004604967-2026-01138
• Device Sequence Number: 9318887
• Product Code: BZD
• UDI-Device Identifier: 00619498373079
• UDI-Public: (01)00619498373079(10)1857281
• Combination Product (Y/N): N
• Initial Reporter State: MN
• PMA/510(K) Number: K140159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 37307
• Device Catalogue Number: 37307
• Device Lot Number: 1857281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 38 KG