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

Model Number 27093

Device Problems Failure to Calibrate (2440); Protective Measures Problem (3015)

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

Event Date 02/05/2023

Event Type  malfunction  

Event Description

It was reported to resmed that an astral device displayed an error message (sf101) related to pressure measurement.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.Evaluation revealed the device failed to complete its service test.Review of the error logs confirmed the reported complaint.The device software was upgraded and pneumatic block replaced to address the issues.The device was serviced and fully tested before it was returned to the customer.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: 17056239
• MDR Text Key: 317092095
• Report Number: 3004604967-2023-00389
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270934
• UDI-Public: (01)00619498270934(10)1555462
• 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
• Report Date: 06/02/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Distributor Facility Aware Date: 05/09/2023
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/02/2023
• Date Device Manufactured: 08/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1