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

Model Number 27052

Device Problem Complete Loss of Power (4015)

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

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

The device was received by resmed for an engineering investigation.The reported complaint could not be reproduced during initial evaluation.Review of the device data logs revealed no alarms or error messages.The investigation methods, results and conclusion are not finalized at this stage.If more information becomes available, a supplemental report will be submitted.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral 100 device powered down unexpectedly and did not power back on.The patient was removed from the device, manually ventilated and placed on a different device.

Event Description

It was reported to resmed that an astral 100 device powered down unexpectedly and did not power back on.The patient was removed from the device, manually ventilated and placed on a different device.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs could not confirm the reported complaint.Performance testing could not reproduce the reported complaint.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).

• Brand Name: ASTRAL 100 DEU
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 18358478
• MDR Text Key: 330904096
• Report Number: 3004604967-2023-00695
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K172875
• 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,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 27052
• Device Catalogue Number: 27052
• Device Lot Number: 1209474
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/18/2024
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1