MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER; Ventilator, continuous, facility use

Model Number 27003

Device Problems Failure to Charge (1085); Device Displays Incorrect Message (2591)

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

Event Date 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the reported battery error message and could not reproduce the reported device failed to charge its internal battery.The internal battery was replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device displayed a battery error message and failed to charge its internal battery.There was no patient involvement reported.

Event Description

It was reported to resmed that an astral device displayed a battery error message and failed to charge its internal battery.There was no patient involvement reported.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs confirmed the reported complaint.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported battery error message was due to to an intermittent connection with the battery while the battery charger fault alarms were due to device operation in a temperature outside of the device specification.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference: (b)(4).

• Brand Name: ASTRAL 150 - AMER
• Type of Device: Ventilator, continuous, facility use
• 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: 15256257
• MDR Text Key: 302271788
• Report Number: 3004604967-2022-00551
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)190313(10)1361913
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/18/2022
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1