MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER

Model Number	27003
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.Resmed reference #: (b)(4).
Event or Problem Description
It was reported to resmed that an astral device failed to detect an external power source and was depleting its internal battery.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 7360853
• Report Number: 3004604967-2018-00478
• Device Sequence Number: 16514651
• Product Code: CBK
• UDI-Device Identifier: 00619498279197
• UDI-Public: (01)00619498279197(11)160720(10)1188198
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/22/2018

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: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/27/2018
• Device Age: 18 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1