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

Model Number 27003

Device Problem Failure to Power Up (1476)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an investigation can be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.If further information becomes available, a follow-up report will be submitted.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device did not power on.The device was not in patient use when the reported event occurred.

• 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
• MDR Report Key: 19168717
• MDR Text Key: 340876047
• Report Number: 3007573469-2024-00101
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)230608(10)1710195
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2024
• Distributor Facility Aware Date: 03/25/2024
• Device Age: 9 MO
• Date Report to Manufacturer: 04/23/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2024
• Date Device Manufactured: 06/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1