MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - FUKUDA

Model Number 27093

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.(b)(4).

Event Description

It was reported to resmed that an astral device displayed a battery communications lost alarm.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 displayed a battery communications lost alarm.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 and review of the device data logs could not reproduce or confirm a battery communications lost alarm.The internal battery was replaced as a precaution.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

• Brand Name: ASTRAL 150 - FUKUDA
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11276583
• MDR Text Key: 230227728
• Report Number: 3007573469-2021-00226
• Device Sequence Number: 1
• Product Code: NOU
• 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: 03/26/2021

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: 27093
• Device Catalogue Number: 27093
• Device Lot Number: 1431751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2021
• Distributor Facility Aware Date: 03/15/2021
• Device Age: 11 MO
• Date Report to Manufacturer: 03/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1