MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - APAC2

Model Number 27088

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

It was reported to resmed that an astral device displayed a battery error message.The device was not in patient use when the reported event occurred.

Manufacturer Narrative

The astral device was returned to a resmed authorized third party service center.Evaluation confirmed the reported complaint.The internal battery was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).

Manufacturer Narrative

Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to an intermittent connection with the battery.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device displayed a battery error message.The device was not in patient use when the reported event occurred.

• Brand Name: ASTRAL 150 - APAC2
• 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: 14570177
• MDR Text Key: 298246424
• Report Number: 3004604967-2022-00382
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270880
• UDI-Public: (01)00619498270880(10)1462990
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K172875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27088
• Device Catalogue Number: 27088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Distributor Facility Aware Date: 06/20/2022
• Date Manufacturer Received: 06/20/2022
• Date Device Manufactured: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1