MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - AMER

Model Number 27001

Device Problems Battery Problem (2885); Protective Measures Problem (3015); Unexpected Shutdown (4019)

Patient Problem Loss of consciousness (2418)

Event Type  Injury  

Manufacturer Narrative

The device was received by resmed and an evaluation confirmed the complaint.The super capacitor test failed during testing of the device.The main circuit board was replaced to resolve the 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 100 device battery was charged to 92% when a critically low battery alarm occurred and the device shut off while in use on a patient.It was reported the patient was found unresponsive, manually ventilated, hospitalized and released from the hospital.

Event Description

It was reported to resmed that an astral 100 device battery was charged to 92% when a critically low battery alarm occurred and the device shut off while in use on a patient.It was reported the patient was found unresponsive, manually ventilated, hospitalized and released from the hospital.

Manufacturer Narrative

The astral device main circuit board & device data logs were returned to resmed for an investigation.Review of the device data logs revealed occurrences of the device powering down while using its internal battery, internal battery degraded warning alarms, an error message (sf180) related to a battery charger fault and an external battery communications lost alarm.Review of the device data logs could not confirm that the battery was charged to 92% when a critically low battery alarm occurred.Visual inspection of the main circuit board revealed markings around of the super capacitor terminals, however, the super capacitor test passed during testing of the device.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the device powered down while using its internal battery, internal battery degraded warning alarm and sf180 were due to an isolated component failure within the device battery assembly while the external communications lost alarm was due to a software issue.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• Brand Name: ASTRAL 100 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9528055
• MDR Text Key: 176302890
• Report Number: 3007573469-2019-00490
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)180208(10)1289389
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 27001
• Device Catalogue Number: 27001
• Device Lot Number: 1289389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2021
• Distributor Facility Aware Date: 08/20/2020
• Device Age: 22 MO
• Event Location: Home
• Date Report to Manufacturer: 02/05/2021
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 45