MAUDE Adverse Event Report: RESMED LTD ASTRAL BATTERY PACK

Model Number 19620

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed 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.Resmed reference #: (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 serious injury reported as a result of this incident.

Manufacturer Narrative

Based on all available evidence and complaint investigations of a similar nature, an 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.Resmed reference #: (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 serious injury reported as a result of this incident.

• Brand Name: ASTRAL BATTERY PACK
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11566126
• MDR Text Key: 243556668
• Report Number: 3004604967-2021-00442
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• 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
• Distributor Facility Aware Date: 07/05/2021
• Date Manufacturer Received: 07/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1