MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER

Model Number 27003

Device Problem Failure to Calibrate (2440)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the reported complaint.Visual inspection revealed the buzzer assembly was disconnected from the main circuit board.The buzzer assembly was reconnected to the main circuit board to address the issue.During evaluation, the device failed to complete its internal self test.The pneumatic block sensor circuit board was replaced to address the 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 the audio on an astral device was not functioning.There was no patient harm or a serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Visual inspection of the pneumatic block revealed contamination.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported device failed to complete its internal self test was due to contamination of the device pneumatic block.The reported audio not functioning was confirmed.In the prior service in (b)(6) 2020, the device passed an alarm test and all functional tests.The root cause for buzzer assembly disconnected from main circuit board is unable to be determined.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 the audio of an astral device was not functioning and failed to complete its internal self-test.There was no patient harm or a 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
• MDR Report Key: 11675938
• MDR Text Key: 245779404
• Report Number: 3007573469-2021-00502
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

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: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2021
• Distributor Facility Aware Date: 07/21/2021
• Device Age: 79 MO
• Date Report to Manufacturer: 08/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1