MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - AMER

Model Number 27001

Device Problems Device Displays Incorrect Message (2591); Charging Problem (2892)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs confirmed the reported complaint of the internal battery degraded warning alarm and an error message (sf180) related to a battery charger fault.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to an isolated component failure within the device battery assembly.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.(b)(4).

Event Description

It was reported to resmed that an astral device displayed error messages related to a power fault and charging issue and internal battery degraded warning alarm.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 100 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11277011
• MDR Text Key: 230227102
• Report Number: 3007573469-2021-00234
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)190516(10)1381853
• 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
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27001
• Device Catalogue Number: 27001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2021
• Distributor Facility Aware Date: 01/08/2021
• Device Age: 19 MO
• Date Report to Manufacturer: 02/03/2021
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1