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

Model Number 27081

Device Problems Pressure Problem (3012); Protective Measures Problem (3015)

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

Event Date 09/19/2023

Event Type  malfunction  

Manufacturer Narrative

Visual inspection revealed contamination within the pneumatic block.The pneumatic block requires replacement to address the issues.Resmed reference#: pr (b)(4).

Event Description

It was reported to resmed that an astral device did not deliver the prescribed pressures.During resmed evaluation, the device displayed an error message (sf147) related to the main blower.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 100 - APAC
• 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: 17968659
• MDR Text Key: 326085147
• Report Number: 3007573469-2023-00585
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270811
• UDI-Public: (01)00619498270811(10)1472573
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2023

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: 27081
• Device Catalogue Number: 27081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2023
• Distributor Facility Aware Date: 09/19/2023
• Device Age: 37 MO
• Date Report to Manufacturer: 10/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1