MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - FUKUDA

Model Number 27093

Device Problem Failure to Calibrate (2440)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint.The non-return valve (nrv) assembly was replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device failed to complete its internal self-test.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
• MDR Report Key: 11592856
• MDR Text Key: 243612127
• Report Number: 3007573469-2021-00468
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270934
• UDI-Public: (01)00619498270934(10)1436355
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2021

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: 03/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2021
• Distributor Facility Aware Date: 03/12/2021
• Device Age: 13 MO
• Date Report to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1