MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL 150 - AMER; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27003

Device Problems Protective Measures Problem (3015); Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to resmed.Review of the device event logs confirmed battery inoperable alarms and revealed a total power failure alarm.The internal battery was replaced to address the issues.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device displayed a battery inoperable error message.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - AMER
• Type of Device: 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: 18505530
• MDR Text Key: 333198583
• Report Number: 3004604967-2024-00015
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)220120(10)1590708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/13/2023
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1