MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER

Model Number 27003

Device Problem Pressure Problem (3012)

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

Event Date 11/14/2022

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to resmed.Evaluation confirmed the reported complaint.Review of the device data logs revealed an error message (sf75) related to software calibration.Visual inspection of the pneumatic block revealed water damage/contamination.The pneumatic block assembly was replaced to address the issues.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 displayed an error message (sf101) related to pressure measurement.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - AMER
• 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: 15965754
• MDR Text Key: 305349126
• Report Number: 3004604967-2022-00819
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)200728(10)1471192
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2022

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: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/14/2022
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1