MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER

Model Number 27003

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/21/2022

Event Type  malfunction  

Event Description

It was reported to resmed that an astral device displayed an error message (sf188) indicating a safety assert system fault.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint.Review of the error logs revealed an error message (sf82) related to an alarm system fault.The main circuit board and pneumatic block were replaced to address the issues.The device was serviced and fully tested before it was returned to the customer.Resmed reference #: (b)(4).

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs and performance testing confirmed the reported sf188 and sf82.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to an isolated component 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 (sf188) indicating a safety assert system fault.During resmed evaluation, review of the error logs revealed an error message (sf82) related to an alarm system fault.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: 14145720
• MDR Text Key: 294799996
• Report Number: 3004604967-2022-00264
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)210915(10)1560561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

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: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/03/2022
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 06/03/2022
• Supplement Dates FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1