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

Model Number 27053

Device Problems Battery Problem (2885); Protective Measures Problem (3015); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to resmed.Evaluation did not confirm or replicate the reported ventilation issue.However, the reported battery issue was confirmed.The internal battery will be replaced to address the issue.The device will be serviced and fully tested before returned to the customer.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device was not ventilating properly and displayed a battery error message.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - DEU
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 17280343
• MDR Text Key: 318604252
• Report Number: 3004604967-2023-00426
• 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
• Report Date: 07/07/2023

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: 27053
• Device Catalogue Number: 27053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/09/2023
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1