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

Model Number 27093

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 03/09/2023

Event Type  malfunction  

Event Description

It was reported to resmed that an astral device alarmed and stopped delivering ventilation while in use on a patient.The device was removed from the patient and the patient was manually ventilated.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to a third party service center and an evaluation confirmed the reported complaint.The investigation methods, results, and conclusions are not finalized at this stage.If further information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device alarmed and stopped delivering ventilation while in use on a patient.The device was removed from the patient and the patient was manually ventilated.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.The expiratory flow sensor was replaced to address the issue.Based on all available evidence and complaint investigations of a similar nature, the investigation determined the reported complaint was due to contamination.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: 16738247
• MDR Text Key: 313326159
• Report Number: 3004604967-2023-00277
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270934
• UDI-Public: (01)00619498270934(10)1443272
• 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: 08/08/2023

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: Health Professional
• Device Model Number: 27093
• Device Catalogue Number: 27093
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/17/2023
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female