MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - APAC

Model Number 27081

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.(b)(4).

Event Description

It was reported to resmed that an astral device had batteries with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The device was returned to an authorized resmed third party service center and an evaluation confirmed the complaint.The internal battery was replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.Based on all available evidence, an investigation determined that the reported complaint was due to a faulty/defective internal 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 had batteries with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 100 - APAC
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11180010
• MDR Text Key: 228214036
• Report Number: 3004604967-2021-00112
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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?: No
• Distributor Facility Aware Date: 05/16/2021
• Date Manufacturer Received: 05/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1