MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - DEU

Model Number 27053

Device Problems Failure to Charge (1085); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

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'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 powered down unexpectedly.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.Review of the device data logs confirmed the reported complaint and also revealed battery charger fault alarms and corrupted battery cycle count.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint and battery charger fault alarms were due to an isolated component failure within the device battery assembly while the corrupted battery cycle count was due to a software issue.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 powered down unexpectedly.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - DEU
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9079930
• MDR Text Key: 169121635
• Report Number: 3007573469-2019-00288
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

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: 27053
• Device Catalogue Number: 27053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/26/2019
• Distributor Facility Aware Date: 10/31/2019
• Device Age: 63 MO
• Date Report to Manufacturer: 11/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 10/31/2019
• Supplement Dates FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1