MAUDE Adverse Event Report: RESMED LTD BATTERIE EXTERNE ASTRAL

Model Number 27918

Device Problem Premature Discharge of Battery (1057)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for an extensive engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device had an external 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 astral device was returned to resmed for an investigation.Review of the device data logs confirmed the reported complaint.The external battery was replaced to address the issue.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 external battery assembly.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 an external battery with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: BATTERIE EXTERNE ASTRAL
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12138196
• MDR Text Key: 262889732
• Report Number: 3004604967-2021-00770
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/25/2021
• Distributor Facility Aware Date: 07/08/2021
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1