MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - AMER; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27001

Device Problems Unexpected Therapeutic Results (1631); Unexpected Shutdown (4019)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

It was reported to resmed that an astral 100 device unexpectedly stopped ventilating during device use.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.Resmed reference#: (b)(4).

Manufacturer Narrative

The astral device was not returned to resmed.An investigation was performed on all available information.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#:(b)(4).

Event Description

It was reported to resmed that an astral 100 device unexpectedly stopped ventilation during use on a patient.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 100 device unexpectedly stopped ventilation while in use on a patient.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was not returned to resmed.Review of the device data logs confirmed total power failure alarms and abnormal restart alarms.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to intermittent battery signal.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference: (b)(4).

• Brand Name: ASTRAL 100 - AMER
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 15712812
• MDR Text Key: 302921143
• Report Number: 3007573469-2022-00719
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)200614(10)1462832
• 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,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2024
• Distributor Facility Aware Date: 03/27/2023
• Device Age: 27 MO
• Date Report to Manufacturer: 04/24/2024
• Date Manufacturer Received: 03/27/2023
• Date Device Manufactured: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1