MAUDE Adverse Event Report: RESMED LTD ASTRAL BATTERY PACK

Model Number 19620

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned and an evaluation confirmed the complaint.The internal battery was replaced to resolve the issue.The device was serviced and fully tested before it was returned to the customer.(b)(4).

Event Description

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

Event Description

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

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs confirmed the reported complaint and revealed an 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 resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• Brand Name: ASTRAL BATTERY PACK
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9802985
• MDR Text Key: 188241145
• Report Number: 3007573469-2020-00340
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 19620
• Device Catalogue Number: 19620
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2020
• Distributor Facility Aware Date: 12/08/2020
• Date Report to Manufacturer: 12/29/2020
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1