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

Model Number	37211
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 an aircurve 10 vauto device allegedly caught fire.There was no patient injury reported as a result of this event.

• Brand Name: AIRCURVE 10 VAUTO USA CO
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 7429103
• Report Number: 3004604967-2018-00612
• Device Sequence Number: 18880360
• Product Code: BZD
• UDI-Device Identifier: 00619498372119
• UDI-Public: (01)00619498372119(10)1189295
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K160822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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: 37211
• Device Catalogue Number: 37211
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/12/2018
• Device Age: 20 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1