MAUDE Adverse Event Report: RESMED LTD AIRCURVE 10 VAUTO USA TRI

Model Number	37212
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Respiratory Distress (2045)
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
It was reported to resmed that a patient was hospitalized with respiratory distress due to an unspecified malfunction of an aircurve 10 vauto.

• Brand Name: AIRCURVE 10 VAUTO USA TRI
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 8732188
• Report Number: 3004604967-2019-00199
• Device Sequence Number: 2638438
• Product Code: BZD
• UDI-Device Identifier: 00619498372126
• UDI-Public: (01)00619498372126(10)1275463
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 37212
• Device Catalogue Number: 37212
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/10/2019
• Device Age: 18 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 90