MAUDE Adverse Event Report: RESMED LTD ASTRAL PSU SLIM LINE

Model Number	27966
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to an authorized resmed third party service center and an evaluation confirmed the complaint.The power supply unit was replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference #: (b)(4).
Event or Problem Description
It was reported to resmed that an astral power supply unit (psu) was inoperable.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL PSU SLIM LINE
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 7392887
• Report Number: 3004604967-2018-00545
• Device Sequence Number: 1677889
• Product Code: CBK
• UDI-Device Identifier: 00619498279661
• UDI-Public: (01)00619498279661(10)1253994
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K152068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/03/2018

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: Medical Equipment Company Technician/Representative
• Device Model Number: 27966
• Device Catalogue Number: 27966
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/14/2018
• Device Age: 7 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1