MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER

Model Number 27003

Device Problems Battery Problem (2885); Complete Loss of Power (4015)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The device was returned to resmed for an 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).Evaluation pending.

Event Description

It was reported to resmed that a patient expired while on an astral device.It was reported the internal battery was dead when the respiratory therapist picked up the device from the patient's home.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs revealed a total power failure event due to internal battery depletion.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to user error.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: pr (b)(4).

Event Description

It was reported to resmed that a patient expired while on an astral device.It was reported the internal battery was fully discharged when the respiratory therapist picked up the device from the patient's home.

• Brand Name: ASTRAL 150 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9454614
• MDR Text Key: 170414079
• Report Number: 3007573469-2019-00449
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)170212(10)1222100
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 27003
• Device Catalogue Number: 27003
• Device Lot Number: 1222100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2020
• Distributor Facility Aware Date: 12/15/2019
• Device Age: 33 MO
• Event Location: Home
• Date Report to Manufacturer: 01/10/2020
• Date Manufacturer Received: 12/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death