MAUDE Adverse Event Report: RESMED LTD ACUCARE HFNC - MEDIUM (20PK)

Model Number	23004
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	04/15/2021
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.Resmed reference #: (b)(4).
Event or Problem Description
It was reported to resmed that a hospital patient had an oxygen desaturation due to a tear in the corrugated tubing of an acucare mask.The mask was delivering oxygen to the patient at the time their desaturation was observed.The tear in the mask tubing did not result in permanent harm to the patient.

• Brand Name: ACUCARE HFNC - MEDIUM (20PK)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11816562
• Report Number: 3007573469-2021-00593
• Device Sequence Number: 17201164
• Product Code: CAT
• UDI-Device Identifier: 00619498230044
• UDI-Public: (01)00619498230044(10)1478299
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2021
• Report Date (Section F): 05/12/2021

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: Lay User/Patient
• Device Model Number: 23004
• Device Catalogue Number: 23004
• Device Lot Number: 1478299
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/12/2021