MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER

Model Number 27003

Device Problems Failure to Calibrate (2440); Battery Problem (2885); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device to returned to resmed and an initial evaluation confirmed the complaint.When more information is available, a supplemental report will be submitted.Resmed reference # (b)(4).

Event Description

It was reported to resmed that an astral device failed to complete its internal self-test.There was no patient harm or a serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Performance testing confirmed the reported complaint.The pneumatic block was replaced to address this issue.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to contamination of the device pneumatic block.Review of the device data logs revealed an internal battery error message and an error message (sf180) related to a battery charger fault.The internal battery was replaced to address this issue.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the root cause was an isolated component failure within the device battery assembly.Resmed's risk analysis for this failure made concludes that the risk is acceptable.Resmed reference # (b)(4).

Event Description

It was reported to resmed that an astral device failed to complete its internal self-test.There was no patient harm or a serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9200332
• MDR Text Key: 176590087
• Report Number: 3007573469-2019-00304
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)171105(10)1273646
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/19/2019

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: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2019
• Distributor Facility Aware Date: 11/20/2019
• Device Age: 23 MO
• Date Report to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2019
• Supplement Dates Manufacturer Received: 11/20/2019
• Supplement Dates FDA Received: 12/20/2019
• 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