MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - FUKUDA

Model Number 27093

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/15/2022

Event Type  malfunction  

Event Description

It was reported to resmed that an astral device displayed an error message (sf191) related to loss of communication with outlet flow sensor.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The device was returned to an authorized resmed third party service center for an evaluation.Review of the error log history confirmed the complaint.The pneumatic block was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference #: (b)(4).

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 isolated component failure within the device pneumatic block.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device displayed an error message (sf191) related to loss of communication with outlet flow sensor.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - FUKUDA
• 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: 14147950
• MDR Text Key: 295325787
• Report Number: 3004604967-2022-00269
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270934
• UDI-Public: (01)00619498270934(10)1452090
• 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: 06/03/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Distributor Facility Aware Date: 05/12/2022
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 06/03/2022
• Date Device Manufactured: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1