MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - FUKUDA

Model Number 27093

Device Problems Mechanical Problem (1384); Poor Quality Image (1408); Protective Measures Problem (3015); Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for an extensive engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.Resmed reference #:(b)(4).

Event Description

It was reported to resmed that an astral device stopped ventilation and had a black screen.There was no patient harm or serious injury reported as a result of this incident.

Event Description

It was reported to resmed that an astral device stopped ventilation and had a black screen.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs revealed multiple safety reset alarms.Performance testing confirmed the reported complaint.Visual inspection of the device revealed an electrical signal contact pin between the internal battery¿s terminal to the main circuit board was defective.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 failure within the device main circuit board.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

• Brand Name: ASTRAL 150 - FUKUDA
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12991084
• MDR Text Key: 283830657
• Report Number: 3007573469-2021-01236
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270934
• UDI-Public: (01)00619498270934(10)1348024
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27093
• Device Catalogue Number: 27093
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2022
• Distributor Facility Aware Date: 02/24/2022
• Device Age: 35 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1