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

Model Number 27918

Device Problems Premature Discharge of Battery (1057); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

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.(b)(4).

Event Description

It was reported to resmed that an astral device had a power source detection issue.There was no patient harm or serious injury reported as a result of this incident.

Event Description

It was reported to resmed that an astral device had a power source detection issue.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.Performance testing reproduced the reported complaint.Review of the device data logs revealed an external battery with a reduced level of capacity.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported event 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).

• 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: 8243229
• MDR Text Key: 133056492
• Report Number: 3004604967-2019-00051
• 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: 02/20/2019

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: 12/17/2018
• Distributor Facility Aware Date: 02/07/2019
• Device Age: 46 MO
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1