MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL EXTERNAL BATTERY, AMERICAS; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number	27919
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to resmed that an astral device had an external battery with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.
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).

• Brand Name: ASTRAL EXTERNAL BATTERY, AMERICAS
• Common Device Name: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 19480988
• Report Number: 3004604967-2024-00148
• Device Sequence Number: 18119134
• Product Code: NOU
• UDI-Device Identifier: 00619498279197
• UDI-Public: (01)00619498279197(11)231116(10)1743940
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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: 27919
• Device Catalogue Number: 27919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/07/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown