MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27003

Device Problems Contamination (1120); Moisture Damage (1405)

Patient Problems Dyspnea (1816); Diaphoresis (2452)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to resmed that a patient using an astral device went into respiratory distress with severe retractions and diaphoresis allegedly due to a water saturated device filter and water ingress of the ventilator.User reported recalibration of the circuit failed and replacement of the expiratory flow sensor with no resolution.Patient was manually ventilated and placed on an alternate, non-resmed ventilator.

Manufacturer Narrative

Based on our testing of the returned device with serial number (b)(6), the device functioned as expected.Review of the device data logs confirmed two occurrences of ¿check circuit and filters for blockages, leak or water.Repeat learn circuit.¿ alarm which indicates device detection of circuit blockages, leaks or build up of water.Pursuant to the resmed internal investigation report, no device fault was found and the device was confirmed to meet specifications.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).Fda reference#: medwatch (b)(4).

Event Description

It was reported to resmed that a patient using an astral device went into respiratory distress with severe retractions and diaphoresis allegedly due to a water saturated device filter and water ingress of the ventilator.User reported recalibration of the circuit failed and replacement of the expiratory flow sensor with no resolution.Patient was manually ventilated and placed on an alternate, non-resmed ventilator.

• Brand Name: ASTRAL 150 - 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: 13080323
• MDR Text Key: 282986046
• Report Number: 3007573469-2021-01260
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)210825(10)1558100
• 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
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27003
• Device Catalogue Number: 27003
• Device Lot Number: 1558100
• 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: 05/05/2023
• Distributor Facility Aware Date: 04/17/2023
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2023
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female