MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 -EUR4

Model Number 27063

Device Problems Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs could not confirm the reported complaint but did reveal an error message (sf219) related to a pneumatic block watchdog alarm that did not occur during ventilation.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a software issue.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 stopped ventilation during use on a patient.The patient was removed from the device and placed on a different device.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 -EUR4
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11282609
• MDR Text Key: 231413369
• Report Number: 3004604967-2021-00237
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27063
• Device Catalogue Number: 27063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/07/2021
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1