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

Model Number 27074

Device Problems Power Problem (3010); Protective Measures Problem (3015); Complete Loss of Power (4015)

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

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for an engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.Resmed reference #: pr (b)(4).H3 other text : device received; evaluation pending.

Event Description

It was reported to resmed that an astral device powered down.There was no patient harm or serious injury reported as a result of this incident.

Event Description

It was reported to resmed that an astral device powered down.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Performance testing and review of the device data logs confirmed the reported complaint.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a software issue.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: 18993598
• MDR Text Key: 338825445
• Report Number: 3007573469-2024-00080
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270743
• UDI-Public: (01)00619498270743(10)1581451
• 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,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 04/29/2024
• Distributor Facility Aware Date: 04/01/2024
• Device Age: 27 MO
• Date Report to Manufacturer: 04/29/2024
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1