MAUDE Adverse Event Report: RESMED LTD ASTRAL EXTERNAL BATTERY, ROW

Model Number 27918

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint.The 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 had a battery 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 resmed and an evaluation was performed.The reported complaint could not be confirmed.The battery was replaced as a precaution.The device was serviced and fully tested before it was returned to the customer.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 a battery with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL EXTERNAL BATTERY, ROW
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 10053469
• MDR Text Key: 190953237
• Report Number: 3007573469-2020-00597
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27918
• Device Catalogue Number: 27918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2020
• Distributor Facility Aware Date: 07/07/2020
• Device Age: 7 MO
• Date Report to Manufacturer: 07/29/2020
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1