MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 DBL KIT FRA; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27074

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

It was reported to resmed that an astral device stopped unexpectedly 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 returned to resmed.The investigation methods, results, and conclusions are not finalized at this stage.If further information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device stopped unexpectedly 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 returned to resmed for an investigation.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 150 DBL KIT FRA
• 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: 17437976
• MDR Text Key: 320205285
• Report Number: 3007573469-2023-00450
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270743
• UDI-Public: (01)00619498270743(11)180429(10)1304274
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/24/2023

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: 27074
• Device Catalogue Number: 27074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2023
• Distributor Facility Aware Date: 08/02/2023
• Device Age: 61 MO
• Date Report to Manufacturer: 08/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1