MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL 150 DBL KIT FRA; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27074

Device Problem Unexpected Shutdown (4019)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

During resmed evaluation of an astral device, review of the device data logs revealed total power failure alarms.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to an intermittent battery signal.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• Brand Name: ASTRAL 150 DBL KIT FRA
• 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: 19168642
• MDR Text Key: 340876477
• Report Number: 3007573469-2024-00100
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270743
• UDI-Public: (01)00619498270743(10)1391881
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 27074
• Device Catalogue Number: 27074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• 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: 5 MO
• Date Report to Manufacturer: 04/23/2024
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1