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

Model Number 27093

Device Problems Inadequate User Interface (2958); Output Problem (3005); Key or Button Unresponsive/not Working (4063)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to a resmed authorized third party service center.Evaluation confirmed the reported complaint.The investigation methods, results, and conclusion are not finalized at this stage.If more information becomes available, a supplemental report will be submitted.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device had an unresponsive touchscreen and would not start ventilation.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 had an unresponsive touchscreen and would not start ventilation.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 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 physical damage.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• Brand Name: ASTRAL 150 - FUKUDA
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 15859586
• MDR Text Key: 304372630
• Report Number: 3004604967-2022-00784
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270934
• UDI-Public: (01)00619498270934(10)1474737
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

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: 27093
• Device Catalogue Number: 27093
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/22/2023
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 02/22/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1