MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - AMER

Model Number 27001

Device Problem Break (1069)

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

Event Date 10/15/2021

Event Type  malfunction  

Event Description

It was reported to resmed that an astral device displayed displayed an error message (sf147) related to the main blower.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.Visual inspection of the main blower motor revealed contamination.The pneumatic block was replaced to address the reported complaint.The device was serviced and fully tested before it was returned to the customer.Resmed reference #: (b)(4).

Manufacturer Narrative

Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to contamination.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 (sf147) related to the main blower.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 100 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12911230
• MDR Text Key: 282960890
• Report Number: 3007573469-2021-01189
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

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: 27001
• Device Catalogue Number: 27001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2021
• Distributor Facility Aware Date: 12/01/2021
• Device Age: 85 MO
• Date Report to Manufacturer: 12/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1